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Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

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ClinicalTrials.gov Identifier: NCT00194792
Recruitment Status : Terminated
First Posted : September 19, 2005
Results First Posted : June 6, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hannah Linden, University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Interventions Drug: exemestane
Drug: triptorelin pamoate
Drug: capecitabine
Drug: methotrexate
Drug: vinorelbine tartrate
Drug: paclitaxel
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Other: laboratory biomarker analysis
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 28
Completed 27
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
55
(35 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
28
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
2
   7.1%
Not Hispanic or Latino
25
  89.3%
Unknown or Not Reported
1
   3.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
  92.9%
More than one race
1
   3.6%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Clinical Response
Hide Description Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
Time Frame 1 month
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
19
  70.4%
2.Primary Outcome
Title Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
Hide Description Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.
Time Frame From date of treatment start to surgery
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Disease-free Survival
Hide Description Kaplan-Meier estimate assessed at 5 years
Time Frame Up to 5 years
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: disease free survival probability
0.76
(0.61 to 0.95)
4.Primary Outcome
Title Overall Survival
Hide Description From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.
Time Frame Up to 5 years
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.88
(0.76 to 1)
5.Primary Outcome
Title Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
Hide Description Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
Time Frame Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: events
Grade 2 80
Grade 3 12
Grade 4 0
Fatal toxicity 0
6.Primary Outcome
Title Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Hide Description Count of patients with dose reduction, treatment interruption, or treatment discontinuation.
Time Frame During adjuvant and neoadjuvant chemotherapy
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[Not Specified]
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Adjuvant therapy
1
   3.7%
Neoadjuvant therapy
11
  40.7%
7.Secondary Outcome
Title Correlation of Molecular Markers With Response, Time to Progression, and Survival
Hide Description [Not Specified]
Time Frame Weekly during CHB and XMN and pacitaxel
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Molecular marker data was not collected for this cohort and thus not possible to report results for this outcome.
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Hormone Therapy and Chemotherapy)
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exemestane: Given PO

triptorelin pamoate: Given IM

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

paclitaxel: Given IV

therapeutic conventional surgery: Undergo lumpectomy or mastectomy

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (Hormone Therapy and Chemotherapy)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Treatment (Hormone Therapy and Chemotherapy)
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Hormone Therapy and Chemotherapy)
Affected / at Risk (%)
Total   23/27 (85.19%) 
Gastrointestinal disorders   
Nausea  16/27 (59.26%) 
Dysgeusia  4/27 (14.81%) 
Diarrhea  7/27 (25.93%) 
Mucositis (GI)  2/27 (7.41%) 
Mucositis (Oral)  6/27 (22.22%) 
Heartburn  2/27 (7.41%) 
Constipation  5/27 (18.52%) 
Pain (abdominal)  3/27 (11.11%) 
GI Upset/Reflux  2/27 (7.41%) 
Vomiting  2/27 (7.41%) 
General disorders   
Fatigue  17/27 (62.96%) 
Fever  4/27 (14.81%) 
Pain (arm)  2/27 (7.41%) 
Pain (neck & jaw)  2/27 (7.41%) 
Pain (back)  4/27 (14.81%) 
Pain (subcostal)  3/27 (11.11%) 
Joint Pain/Muscle Aches  5/27 (18.52%) 
Investigations   
SGOT Increased  9/27 (33.33%) 
SGPT Increased  10/27 (37.04%) 
Albumin Decreased  5/27 (18.52%) 
Potassium Decreased  7/27 (25.93%) 
Neutrophil Count Decreased  14/27 (51.85%) 
Alkaline Phosphatase Increased  6/27 (22.22%) 
Hemoglobin Decreased  16/27 (59.26%) 
White Blood Cells Decreased  18/27 (66.67%) 
Hematocrit Decreased  2/27 (7.41%) 
Hypocalcemia  3/27 (11.11%) 
Sodium Decreased  3/27 (11.11%) 
Lactate Dehydrogenase Increased  7/27 (25.93%) 
Glucose Increased  3/27 (11.11%) 
Musculoskeletal and connective tissue disorders   
Pain (bone)  3/27 (11.11%) 
Nervous system disorders   
Headache  4/27 (14.81%) 
Psychiatric disorders   
Anxiety  4/27 (14.81%) 
Insomnia  6/27 (22.22%) 
Depression  7/27 (25.93%) 
Renal and urinary disorders   
UTI  3/27 (11.11%) 
Reproductive system and breast disorders   
Amenorrhea  2/27 (7.41%) 
Yeast Infection (vaginal)  2/27 (7.41%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/27 (7.41%) 
Common Cold  4/27 (14.81%) 
SOB with activity  3/27 (11.11%) 
Skin and subcutaneous tissue disorders   
Alopecia  3/27 (11.11%) 
Dry Skin (hands)  2/27 (7.41%) 
Hand Foot Syndrome  4/27 (14.81%) 
Rash (Eczema)  2/27 (7.41%) 
Dry Skin  4/27 (14.81%) 
Hyperpigmentation (lymphs)  2/27 (7.41%) 
Vascular disorders   
High Blood Pressure  2/27 (7.41%) 
Hot Flashes/Night Sweats  14/27 (51.85%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hannah Linden
Organization: University of Washington / Seattle Cancer Care Alliance
Phone: 206-288-6989
EMail: hmlinden@uw.edu
Layout table for additonal information
Responsible Party: Hannah Linden, University of Washington
ClinicalTrials.gov Identifier: NCT00194792    
Other Study ID Numbers: 6277
NCI-2010-00549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 14, 2005
First Posted: September 19, 2005
Results First Submitted: April 14, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 11, 2017