Early-Stage Breast Cancer Clinical Trial
Official title:
A Randomized Phase II Trial Evaluating the Performance of Genomic Expression Profiles to Direct the Use of Preoperative Chemotherapy for Early Stage Breast Cancer
This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a "genomic-guided" arm or a "non-guided arm." The "genomic-guided" method (Arm 1) used genomic expression profiling to assign the preoperative therapy (Doxorubicin/Cyclophosphamide (AC) versus Docetaxel/Cyclophosphamide (TC), while Arm 2 used random assignment to these two therapies.
Primary Objective 1 was to test for an arm difference in pathological complete response
rates. Secondary Objective 2 was to estimate and test the difference in pathologic complete
response rates between drug-sensitive patients who received their preferred drug and
drug-resistant patients randomized to AC or TC.
Secondary objectives included: to determine the 60% cutoff for the genomic profiles resulted
in a larger pathologic CR rate for the guided arm than for the unguided arm; to compare the
pathologic CR rates of patients whose genomic predictive probabilities indicated that they
were resistant to both chemotherapy regimens with the pathologic CR rates of patients whose
genomic predictive probabilities indicated that they were sensitive to only one treatment
and who were then randomly assigned to a treatment for which they were resistant (combining
AC and TC subgroups); Secondary Objective 3 in patients with T2 and T3 tumors classified as
requiring mastectomy at baseline, compare the guided and non-guided treatment arms on rates
of breast conserving surgery with negative final margins; Secondary Objective in patients
with T2 tumors classified as potential candidates for breast conservation, compare the
guided and non-guided arms on rates of breast conserving surgery at first attempt; Secondary
Objectives 5, 6, 7 and 8 to correlate genomic profiles (i.e., genomic predictive
probabilities) with clinical response, disease-free survival, sites of recurrence, and
overall survival; Secondary Objective 9:to compare the mean cost of guided versus non-guided
treatment; and Secondary Objective 10 to assess patient perceptions of participating in a
clinical trial that evaluated cancer genomics for preoperative systemic therapy of
early-stage breast cancer.
Objective 10 details: Due to space limitations in the Outcome Measure Description field,
details are supplied here:
To assess patient motivation and participation for study participation in a clinical trial
evaluating cancer genomics for treatment patients provided responses for the following
questions at both baseline (the day of chemotherapy start) and following post-surgical
medical oncology evaluation:
One of the goals of this study is to tailor your cancer treatments for you based upon a
genomic analysis of your tumor. How much did the knowledge that the treatment is potentially
tailored specifically for your tumor influence your decision to participate in this study?
(Select One)
Response 1: I did not know that the treatment was tailored.
Response 2: I do not understand what "tailored treatment based upon genomic analysis of "my
tumor" means.
Response 3: The information that this was a tailored treatment based upon genomic analysis
of my tumor decreased my willingness to participate in this study.
Response 4: The information that this was a tailored treatment based upon genomic analysis
of my tumor was of neutral value in the decision making process to participate in this study
and did not influence my decision to participate.
Response 5: The information that this was a tailored treatment based upon genomic analysis
of my tumor played a minor role in helping me decide to participate in the study.
Response 6: The information that this was a tailored treatment based upon genomic analysis
of my tumor played a major role in helping me decide to participate in the study.
Response 7: The information that this was a tailored treatment based upon genomic analysis
of my tumor was the primary reason that I decided to participate in the study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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