Stage IIIA Breast Cancer Clinical Trial
Official title:
Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will
respond to treatment and plan effective treatment.
PURPOSE: This pilot study is studying how well hormone therapy or chemotherapy before
surgery based on gene expression analysis works in treating patients with breast cancer. The
purpose of this research study is threefold. First, it is to determine if this approach to
treatment is acceptable to participants. Second, it is to determine whether it is feasible
to use the genetic make-up of your breast cancer cells to predict whether your disease will
best respond to chemotherapy or hormonal therapy when given prior to surgery. Third, which
is optional, is to determine if the blood levels of Insulin-like growth factor binding
protein-2 IGFBP-2 can be used to monitor the response of your breast cancer to the treatment
that you receive.
OBJECTIVES:
I. To determine the feasibility of carrying out a large-scale multi-center trial in which RS
would be used to select treatment type in the neoadjuvant setting and whether patients with
intermediate RS are willing to be randomized between hormonal and chemotherapy.
II. To determine whether the type of neoadjuvant therapy (hormonal versus cytotoxic
chemotherapy) chosen on the basis of gene expression profiling will result in consistently
high rates of objective clinical responses in all patients.
III. To determine whether the type of neoadjuvant therapy (hormonal versus cytotoxic
chemotherapy) chosen on the basis of gene expression profiling will facilitate planned
breast-conserving therapy.
IV. To determine whether choosing the type of neoadjuvant therapy (hormonal versus cytotoxic
chemotherapy) on the basis of gene expression profiling will optimize the proportion of
patients overall who have a clinical complete response (cCR).
V. To determine whether choosing the type of neoadjuvant therapy (hormonal versus cytotoxic
chemotherapy) on the basis of gene expression profiling will optimize the pathologic
complete response (pCR) rate in the breast of patients receiving cytotoxic chemotherapy.
VI. To determine whether choosing the type of neoadjuvant therapy (hormonal versus cytotoxic
chemotherapy) on the basis of gene expression profiling will optimize the pCR rate in the
breast and nodes of patients receiving cytotoxic chemotherapy.
VII. To determine whether choosing the type of neoadjuvant therapy (hormonal versus
cytotoxic chemotherapy) on the basis of gene expression profiling will increase the
proportion of patients with Class 0 and 1 residual cancer burden (RCB) in patients receiving
cytotoxic chemotherapy.
OUTLINE: Patients are assigned to 1 of 3 groups based on recurrence score (RS) following
Oncotype Dx gene expression profiling.
GROUP I (Recurrence Score < 11): Patients receive neoadjuvant hormonal therapy comprising
tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6
months in the absence of disease progression or unacceptable toxicity.
GROUP II (Recurrence Score 11-25): Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive neoadjuvant hormonal therapy as in group I.
ARM II: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an
anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or
unacceptable toxicity.
GROUP III (Recurrence Score > 25): Patients receive neoadjuvant chemotherapy as in arm II of
group II.
All patients then undergo surgery and receive hormonal therapy for at least 5 years.
After completion of study treatment, patients are followed up periodically.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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