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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01293032
First received: February 7, 2011
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Group 1 (RS < 11)

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)
Group 2 Arm 1 (RS 11-25)

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)
Group 2 Arm 2 (RS 11-25)

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
Group 3 (RS > 25)

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

Participant Flow for 2 periods

Period 1:   Recurrence Score(RS)Assigned/Randomized
    Group 1 (RS < 11)   Group 2 Arm 1 (RS 11-25)   Group 2 Arm 2 (RS 11-25)   Group 3 (RS > 25)
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 
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 2:   Treatment
    Group 1 (RS < 11)   Group 2 Arm 1 (RS 11-25)   Group 2 Arm 2 (RS 11-25)   Group 3 (RS > 25)
STARTED   12   19 [1]   11   14 
COMPLETED   10   14   10   13 
NOT COMPLETED   2   5   1   1 
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 (RS < 11)

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)
Group 2 Arm 1 (RS 11-25)

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)
Group 2 Arm 2 (RS 11-25)

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
Group 3 (RS > 25)

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 Total of all reporting groups

Baseline Measures
   Group 1 (RS < 11)   Group 2 Arm 1 (RS 11-25)   Group 2 Arm 2 (RS 11-25)   Group 3 (RS > 25)   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   17   16   14   59 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   5   8   13   10   36 
>=65 years   7   9   3   4   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3125  (5.931426)   63.64706  (11.5539)   55.3125  (12.2556)   60.64286  (7.312867)   61.25423729  (10.52188724) 
Gender 
[Units: Participants]
         
Female   12   17   16   14   59 
Male   0   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   1   0   1   0   2 
Not Hispanic or Latino   11   16   15   14   56 
Unknown or Not Reported   0   1   0   0   1 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   5   0   4   2   11 
White   7   17   12   12   48 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
Canada   1   4   2   4   11 
United States   11   13   14   10   48 


  Outcome Measures

1.  Primary:   The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Harry D Bear, MD, PhD
Organization: Virginia Commonwealth University/Massey Cancer Center
phone: 804-828-9325
e-mail: harry.bear@vcuhealth.org



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 ( US NIH Grant/Contract Award Number )
Study First Received: February 7, 2011
Results First Received: April 5, 2016
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board