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A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144012
Recruitment Status : Terminated
First Posted : May 21, 2014
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Trastuzumab
Drug: Trastuzumab Emtansine
Drug: Docetaxel
Enrollment 49
Recruitment Details  
Pre-assignment Details Only 49 participants of the originally planned 561 participants were enrolled in the study at the time of study termination.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Period Title: Overall Study
Started 34 15
Completed 0 0
Not Completed 34 15
Reason Not Completed
Adverse Event             1             0
Death             1             0
Withdrawal by Subject             11             3
Study Terminated by Sponsor             18             12
Other             3             0
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel Total
Hide Arm/Group Description

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Total of all reporting groups
Overall Number of Baseline Participants 34 15 49
Hide Baseline Analysis Population Description
The intention-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 15 participants 49 participants
53.7  (9.5) 51.7  (11.1) 53.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 15 participants 49 participants
Female
34
 100.0%
15
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Median (95% Confidence Interval)
Unit of Measure: months
10.3 [1] 
(4.2 to NA)
8.2
(6.0 to 13.8)
[1]
Not Available (NA) = parameter not estimable due to small number of participants included in analysis
2.Primary Outcome
Title Safety: Percentage of Participants With Adverse Events (AEs)
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
94.1 100
3.Primary Outcome
Title Safety: Percentage of Participants With Grade 3 and 4 AEs
Hide Description Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
20.6 66.7
4.Primary Outcome
Title Percentage of Participants With Adverse Events Leading to Treatment Discontinuation
Hide Description [Not Specified]
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
14.7 20.0
5.Primary Outcome
Title Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption
Hide Description [Not Specified]
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
11.8 33.3
6.Primary Outcome
Title Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction
Hide Description [Not Specified]
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
2.9 26.7
7.Primary Outcome
Title Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)
Hide Description Significant decline in LVEF was defined as LVEF below 50% and decrease from baseline of 15% points or more. Echocardiogram or multiple-gated acquisition (MUGA) scan was used to assess LVEF.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = parameter not estimable due to small number of participants included in analysis
9.Secondary Outcome
Title One-Year Survival Rate
Hide Description One-year survival rate as determined by Kaplan-Meier estimates.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 8 8
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
92.31
(56.64 to 98.88)
100.00 [1] 
(NA to NA)
[1]
NA = parameter not estimable due to small number of participants included in analysis
10.Secondary Outcome
Title OS Truncated at 2 Years
Hide Description OS truncated at 2 years was defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the participant's randomization date censored at 2 years.
Time Frame At 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected and are therefore not reported. The study was terminated before the time point for data collection of this outcome measure.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. Tumor assessments were performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (OR) = CR + PR.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 27 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.1
(28.67 to 68.05)
71.4
(41.90 to 89.60)
12.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions.
Time Frame At time of clinical data cut-off (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 13 10
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(3.5 to NA)
6.2
(4.1 to 11.7)
[1]
NA = parameter not estimable due to small number of participants included in analysis
13.Secondary Outcome
Title Pharmacokinetics: Serum Concentrations of Study Medications
Hide Description Pharmacokinetic (PK) parameters were to be determined in a subset of participants. PK samples from the first 100 Chinese participants were planned to be collected.
Time Frame Day 1, Cycle 1 (Day 1), Day 1, Cycle 2 (Day 22), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
No PK analyses were performed as no participants were enrolled from China and no samples were collected.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine
Hide Description [Not Specified]
Time Frame Day 1, Cycle 1 (Day 1), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Only participants with at least one post-dose sample available for ATA analysis were analyzed for this outcome measure.
Arm/Group Title Arm A: Trastuzumab Emtansine
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
3.0
15.Secondary Outcome
Title Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire
Hide Description The FACT-B (version 4) is a self-reported instrument which measures health-related quality of life (HRQOL) of participants with breast cancer.The FACT-B includes the breast cancer sub-scale (BCS) and is comprised of nine items specific to assessing patients' HRQOL in breast cancer.
Time Frame On the first Day of each 21-day Cycle (Day 1, 22, 43, etc.) and at study drug completion or discontinuation visit (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 1 Number Analyzed 34 participants 15 participants
34
 100.0%
15
 100.0%
Cycle 2 Day 1 Number Analyzed 34 participants 15 participants
34
 100.0%
15
 100.0%
Cycle 3 Day 1 Number Analyzed 33 participants 15 participants
33
 100.0%
15
 100.0%
Cycle 4 Day 1 Number Analyzed 30 participants 14 participants
30
 100.0%
14
 100.0%
Cycle 5 Day 1 Number Analyzed 27 participants 13 participants
27
 100.0%
13
 100.0%
Cycle 6 Day 1 Number Analyzed 23 participants 12 participants
23
 100.0%
12
 100.0%
Cycle 7 Day 1 Number Analyzed 18 participants 11 participants
18
 100.0%
11
 100.0%
Cycle 8 Day 1 Number Analyzed 16 participants 11 participants
16
 100.0%
11
 100.0%
Cycle 9 Day 1 Number Analyzed 15 participants 10 participants
15
 100.0%
10
 100.0%
Cycle 10 Day 1 Number Analyzed 12 participants 7 participants
12
 100.0%
7
 100.0%
Cycle 11 Day 1 Number Analyzed 11 participants 7 participants
11
 100.0%
7
 100.0%
Cycle 12 Day 1 Number Analyzed 9 participants 7 participants
9
 100.0%
7
 100.0%
Cycle 13 Day 1 Number Analyzed 8 participants 5 participants
8
 100.0%
5
 100.0%
Cycle 14 Day 1 Number Analyzed 7 participants 5 participants
7
 100.0%
5
 100.0%
Cycle 15 Day 1 Number Analyzed 6 participants 4 participants
6
 100.0%
4
 100.0%
Cycle 16 Day 1 Number Analyzed 3 participants 4 participants
3
 100.0%
4
 100.0%
Cycle 17 Day 1 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
Cycle 18 Day 1 Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
Cycle 19 Day 1 Number Analyzed 1 participants 1 participants
1
 100.0%
1
 100.0%
Cycle 20 Day 1 Number Analyzed 0 participants 1 participants
0
1
 100.0%
Study Drug Completion/Discontinuation Visit Number Analyzed 34 participants 15 participants
33
  97.1%
13
  86.7%
16.Secondary Outcome
Title Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire
Hide Description The FACT - Taxane is a self-reported instrument which measures the HRQOL of participants receiving taxane containing chemotherapy. The FACT-Taxane consists of 16 items and was designed to assess the impact of taxane treatment-related symptoms from the participant's perspective.
Time Frame Days 1 and 8 of Cycles 1 and 2 and on the first day of each subsequent 21-day cycle thereafter as well as at study drug completion or discontinuation visit (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description:

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

Overall Number of Participants Analyzed 34 15
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 1 Number Analyzed 34 participants 15 participants
27
  79.4%
14
  93.3%
Cycle 1 Day 8 Number Analyzed 34 participants 15 participants
27
  79.4%
15
 100.0%
Cycle 2 Day 1 Number Analyzed 34 participants 15 participants
29
  85.3%
15
 100.0%
Cycle 2 Day 8 Number Analyzed 34 participants 15 participants
29
  85.3%
15
 100.0%
Cycle 3 Day 1 Number Analyzed 33 participants 15 participants
33
 100.0%
15
 100.0%
Cycle 4 Day 1 Number Analyzed 30 participants 14 participants
30
 100.0%
14
 100.0%
Cycle 5 Day 1 Number Analyzed 27 participants 13 participants
27
 100.0%
13
 100.0%
Cycle 6 Day 1 Number Analyzed 23 participants 12 participants
23
 100.0%
12
 100.0%
Cycle 7 Day 1 Number Analyzed 18 participants 11 participants
18
 100.0%
11
 100.0%
Cycle 8 Day 1 Number Analyzed 16 participants 11 participants
16
 100.0%
11
 100.0%
Cycle 9 Day 1 Number Analyzed 15 participants 10 participants
15
 100.0%
10
 100.0%
Cycle 10 Day 1 Number Analyzed 12 participants 7 participants
12
 100.0%
7
 100.0%
Cycle 11 Day 1 Number Analyzed 11 participants 7 participants
11
 100.0%
7
 100.0%
Cycle 12 Day 1 Number Analyzed 9 participants 7 participants
9
 100.0%
7
 100.0%
Cycle 13 Day 1 Number Analyzed 8 participants 5 participants
8
 100.0%
5
 100.0%
Cycle 14 Day 1 Number Analyzed 7 participants 5 participants
7
 100.0%
5
 100.0%
Cycle 15 Day 1 Number Analyzed 6 participants 4 participants
6
 100.0%
4
 100.0%
Cycle 16 Day 1 Number Analyzed 3 participants 4 participants
3
 100.0%
4
 100.0%
Cycle 17 Day 1 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
Cycle 18 Day 1 Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
Cycle 19 Day 1 Number Analyzed 1 participants 1 participants
1
 100.0%
1
 100.0%
Cycle 20 Day 1 Number Analyzed 0 participants 1 participants
0
1
 100.0%
Study Drug Completion/Discontinuation Visit Number Analyzed 34 participants 15 participants
33
  97.1%
13
  86.7%
Time Frame Up to 19 months
Adverse Event Reporting Description The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
 
Arm/Group Title Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Hide Arm/Group Description

Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.

Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.

Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.

Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.

All-Cause Mortality
Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   8/34 (23.53%)   5/15 (33.33%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/34 (0.00%)  3/15 (20.00%) 
Neutropenia  1  1/34 (2.94%)  2/15 (13.33%) 
General disorders     
Pyrexia  1  2/34 (5.88%)  0/15 (0.00%) 
Infections and infestations     
Pneumonia  1  2/34 (5.88%)  1/15 (6.67%) 
Post procedural cellulitis  1  0/34 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/34 (2.94%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Hyperammonaemia  1  1/34 (2.94%)  0/15 (0.00%) 
Nervous system disorders     
Normal pressure hydrocephalus  1  0/34 (0.00%)  1/15 (6.67%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  1/34 (2.94%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/34 (2.94%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Trastuzumab Emtansine Arm B: Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   31/34 (91.18%)   15/15 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/34 (2.94%)  4/15 (26.67%) 
Neutropenia  1  1/34 (2.94%)  6/15 (40.00%) 
Thrombocytopenia  1  7/34 (20.59%)  0/15 (0.00%) 
Cardiac disorders     
Pericardial effusion  1  0/34 (0.00%)  1/15 (6.67%) 
Ear and labyrinth disorders     
Tinnitus  1  2/34 (5.88%)  1/15 (6.67%) 
Eye disorders     
Lacrimation decreased  1  0/34 (0.00%)  1/15 (6.67%) 
Vision blurred  1  0/34 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders     
Abdominal pain  1  5/34 (14.71%)  0/15 (0.00%) 
Abdominal pain upper  1  3/34 (8.82%)  4/15 (26.67%) 
Constipation  1  1/34 (2.94%)  1/15 (6.67%) 
Dental caries  1  0/34 (0.00%)  1/15 (6.67%) 
Diarrhoea  1  7/34 (20.59%)  11/15 (73.33%) 
Dry mouth  1  3/34 (8.82%)  0/15 (0.00%) 
Dyspepsia  1  3/34 (8.82%)  2/15 (13.33%) 
Mouth ulceration  1  0/34 (0.00%)  1/15 (6.67%) 
Nausea  1  11/34 (32.35%)  3/15 (20.00%) 
Stomatitis  1  2/34 (5.88%)  2/15 (13.33%) 
Vomiting  1  2/34 (5.88%)  5/15 (33.33%) 
General disorders     
Asthenia  1  4/34 (11.76%)  1/15 (6.67%) 
Catheter site pain  1  0/34 (0.00%)  1/15 (6.67%) 
Chest discomfort  1  2/34 (5.88%)  0/15 (0.00%) 
Chills  1  3/34 (8.82%)  0/15 (0.00%) 
Device occlusion  1  0/34 (0.00%)  1/15 (6.67%) 
Extravasation  1  1/34 (2.94%)  1/15 (6.67%) 
Face oedema  1  0/34 (0.00%)  1/15 (6.67%) 
Fatigue  1  9/34 (26.47%)  1/15 (6.67%) 
Feeling cold  1  3/34 (8.82%)  1/15 (6.67%) 
Generalised oedema  1  0/34 (0.00%)  4/15 (26.67%) 
Malaise  1  0/34 (0.00%)  2/15 (13.33%) 
Mucosal inflammation  1  0/34 (0.00%)  2/15 (13.33%) 
Oedema peripheral  1  2/34 (5.88%)  5/15 (33.33%) 
Pain  1  0/34 (0.00%)  2/15 (13.33%) 
Pyrexia  1  3/34 (8.82%)  3/15 (20.00%) 
Infections and infestations     
Central nervous system infection  1  0/34 (0.00%)  1/15 (6.67%) 
Groin infection  1  0/34 (0.00%)  1/15 (6.67%) 
Herpes zoster  1  0/34 (0.00%)  2/15 (13.33%) 
Laryngitis  1  0/34 (0.00%)  1/15 (6.67%) 
Nasopharyngitis  1  0/34 (0.00%)  1/15 (6.67%) 
Otitis media  1  0/34 (0.00%)  1/15 (6.67%) 
Paronychia  1  0/34 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  1  13/34 (38.24%)  4/15 (26.67%) 
Urinary tract infection  1  2/34 (5.88%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Contusion  1  3/34 (8.82%)  0/15 (0.00%) 
Seroma  1  0/34 (0.00%)  1/15 (6.67%) 
Investigations     
Alanine aminotransferase increased  1  6/34 (17.65%)  0/15 (0.00%) 
Aspartate aminotransferase increased  1  8/34 (23.53%)  1/15 (6.67%) 
Blood cholesterol increased  1  1/34 (2.94%)  1/15 (6.67%) 
Platelet count decreased  1  3/34 (8.82%)  0/15 (0.00%) 
Weight increased  1  1/34 (2.94%)  4/15 (26.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  6/34 (17.65%)  1/15 (6.67%) 
Hypocalcaemia  1  0/34 (0.00%)  1/15 (6.67%) 
Hypokalaemia  1  1/34 (2.94%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/34 (8.82%)  0/15 (0.00%) 
Back pain  1  1/34 (2.94%)  1/15 (6.67%) 
Flank pain  1  0/34 (0.00%)  1/15 (6.67%) 
Limb discomfort  1  0/34 (0.00%)  1/15 (6.67%) 
Muscle spasms  1  2/34 (5.88%)  0/15 (0.00%) 
Musculoskeletal chest pain  1  0/34 (0.00%)  1/15 (6.67%) 
Musculoskeletal pain  1  2/34 (5.88%)  0/15 (0.00%) 
Myalgia  1  11/34 (32.35%)  8/15 (53.33%) 
Neck pain  1  2/34 (5.88%)  0/15 (0.00%) 
Pain in extremity  1  3/34 (8.82%)  1/15 (6.67%) 
Nervous system disorders     
Dizziness  1  3/34 (8.82%)  4/15 (26.67%) 
Headache  1  11/34 (32.35%)  5/15 (33.33%) 
Hypoaesthesia  1  0/34 (0.00%)  1/15 (6.67%) 
Neuropathy peripheral  1  2/34 (5.88%)  2/15 (13.33%) 
Paraesthesia  1  0/34 (0.00%)  1/15 (6.67%) 
Peripheral sensory neuropathy  1  8/34 (23.53%)  8/15 (53.33%) 
Psychiatric disorders     
Hallucination, auditory  1  0/34 (0.00%)  1/15 (6.67%) 
Insomnia  1  3/34 (8.82%)  3/15 (20.00%) 
Renal and urinary disorders     
Urinary incontinence  1  0/34 (0.00%)  1/15 (6.67%) 
Reproductive system and breast disorders     
Breast discharge  1  2/34 (5.88%)  0/15 (0.00%) 
Breast pain  1  5/34 (14.71%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/34 (29.41%)  0/15 (0.00%) 
Dyspnoea  1  2/34 (5.88%)  3/15 (20.00%) 
Dyspnoea exertional  1  1/34 (2.94%)  1/15 (6.67%) 
Epistaxis  1  4/34 (11.76%)  0/15 (0.00%) 
Oropharyngeal pain  1  0/34 (0.00%)  1/15 (6.67%) 
Pneumonitis  1  0/34 (0.00%)  1/15 (6.67%) 
Productive cough  1  2/34 (5.88%)  0/15 (0.00%) 
Rhinorrhoea  1  2/34 (5.88%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/34 (0.00%)  1/15 (6.67%) 
Alopecia  1  2/34 (5.88%)  10/15 (66.67%) 
Dermatitis  1  0/34 (0.00%)  1/15 (6.67%) 
Dermatitis contact  1  0/34 (0.00%)  2/15 (13.33%) 
Dry skin  1  0/34 (0.00%)  1/15 (6.67%) 
Eczema  1  0/34 (0.00%)  1/15 (6.67%) 
Hyperhidrosis  1  2/34 (5.88%)  0/15 (0.00%) 
Hyperkeratosis  1  0/34 (0.00%)  1/15 (6.67%) 
Nail discolouration  1  0/34 (0.00%)  2/15 (13.33%) 
Nail disorder  1  1/34 (2.94%)  3/15 (20.00%) 
Nail ridging  1  0/34 (0.00%)  1/15 (6.67%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/34 (0.00%)  1/15 (6.67%) 
Pruritus  1  2/34 (5.88%)  0/15 (0.00%) 
Rash  1  2/34 (5.88%)  3/15 (20.00%) 
Skin ulcer  1  0/34 (0.00%)  1/15 (6.67%) 
Urticaria  1  2/34 (5.88%)  0/15 (0.00%) 
Vascular disorders     
Hypertension  1  3/34 (8.82%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Due to early termination of the study only limited data from a small subset (49) of the originally planned study population size (561) are available and were too limited to perform originally planned efficacy analyses as specified in the protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02144012    
Other Study ID Numbers: YO28405
First Submitted: May 19, 2014
First Posted: May 21, 2014
Results First Submitted: January 18, 2017
Results First Posted: March 7, 2017
Last Update Posted: March 7, 2017