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Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01293032
Recruitment Status : Completed
First Posted : February 10, 2011
Results First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Stage II Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Interventions Procedure: Neoadjuvant Therapy
Procedure: Therapeutic Conventional Surgery
Other: Laboratory Biomarker Analysis
Genetic: Gene Expression Analysis
Drug: Systemic Chemotherapy
Drug: Tamoxifen Citrate
Drug: Aromatase Inhibition Therapy
Enrollment 59
Recruitment Details Once a patient consented to this study and was deemed eligible the core biopsy blocks or slides were sent to obtain the Oncotype DX Breast Cancer Assay. After the Recurrence Score(RS) results were available the subject was assigned to Group 1, 2, or 3. If assigned to Group 2 they were randomized to Arm 1 or Arm 2.
Pre-assignment Details 5/64 subjects were not assigned or randomized to an arm: delayed oncotype result, core block lost, discrepancy in a bio-marker test, and two subjects deemed not eligible. There were 5 subjects who refused assigned randomization Group 2 Arm 2. 2/5 subjects who refused Group 2 Arm 2 were treated and evaluable for response on Arm 1.
Arm/Group Title Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25)
Hide Arm/Group Description

Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy

Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy
Period Title: Recurrence Score(RS)Assigned/Randomized
Started 12 17 16 14
Assigned/Randomized to Arm 12 17 16 14
Completed 12 17 11 [1] 14
Not Completed 0 0 5 0
Reason Not Completed
Refused Assigned Arm             0             0             5             0
[1]
2/5 subjects who refused Arm 2(chemo) were treated with Arm 1(hormonal) and evaluable for response.
Period Title: Treatment
Started 12 19 [1] 11 14
Completed 10 14 10 13
Not Completed 2 5 1 1
Reason Not Completed
Adverse Event             0             0             1             1
Withdrawal by Subject             2             4             0             0
Disease Progression, relapse             0             1             0             0
[1]
2/5 subjects who refused Arm 2(chemo) were treated with Arm 1(hormonal) and evaluable for response.
Arm/Group Title Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25) Total
Hide Arm/Group Description

Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy

Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy
Total of all reporting groups
Overall Number of Baseline Participants 12 17 16 14 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  41.7%
8
  47.1%
13
  81.3%
10
  71.4%
36
  61.0%
>=65 years
7
  58.3%
9
  52.9%
3
  18.8%
4
  28.6%
23
  39.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
55.3125  (5.931426) 63.64706  (11.5539) 55.3125  (12.2556) 60.64286  (7.312867) 61.25423729  (10.52188724)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
Female
12
 100.0%
17
 100.0%
16
 100.0%
14
 100.0%
59
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
Hispanic or Latino
1
   8.3%
0
   0.0%
1
   6.3%
0
   0.0%
2
   3.4%
Not Hispanic or Latino
11
  91.7%
16
  94.1%
15
  93.8%
14
 100.0%
56
  94.9%
Unknown or Not Reported
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  41.7%
0
   0.0%
4
  25.0%
2
  14.3%
11
  18.6%
White
7
  58.3%
17
 100.0%
12
  75.0%
12
  85.7%
48
  81.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 16 participants 14 participants 59 participants
Canada 1 4 2 4 11
United States 11 13 14 10 48
1.Primary Outcome
Title The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment
Hide Description The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis.
Arm/Group Title Group 2 (RS 11-25)
Hide Arm/Group Description:
Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.15
(0.051 to 0.319)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events (AEs) that are a result of standard diagnosis and treatment are not being collected and should not be reported.
 
Arm/Group Title Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25)
Hide Arm/Group Description

Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
  • Hormonal therapy:

    • Tamoxifen Citrate (pre-menopausal women) OR
    • Aromatase Inhibition Therapy (post-menopausal women)

Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy

Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.

Treatment:

  • Neoadjuvant therapy
  • Therapeutic conventional surgery
  • Laboratory biomarker analysis/Correlative studies
  • Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
  • Systemic chemotherapy
All-Cause Mortality
Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 (RS < 11) Group 2 Arm 1 (RS 11-25) Group 2 Arm 2 (RS 11-25) Group 3 (RS > 25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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: Harry D Bear, MD, PhD
Organization: Virginia Commonwealth University/Massey Cancer Center
Phone: 804-828-9325
EMail: harry.bear@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01293032     History of Changes
Other Study ID Numbers: MCC-13311
NCI-2010-02342 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016059 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2011
First Posted: February 10, 2011
Results First Submitted: April 5, 2016
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016