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A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less




A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less (IRB 011-199)

Study Description:

This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.

Inclusion Criteria:

» DISEASE CHARACTERISTICS:
» 1. Histologically confirmed invasive breast cancer meeting the following criteria:
» 1-3 node-positive disease (pN1mi, pN1a, pN1b, or pN1c) by sentinel node biopsy or axillary lymph node dissection - Patients with positive sentinel node are not required to undergo full axillary lymph node dissection, at the discretion of the treating physician.
» Positive estrogen receptor (ER) and/or progesterone receptor (PR) status according to American Society of Clinical Research/College of American Pathologists (ASCO/CAP) guidelines - Considered positive if ≥ 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal [normal epithelial elements] and external controls.
» Negative HER-2 as determined by IHC or non-amplified fluorescence in situ hybridization (FISH) or chromogen in situ hybridization (CISH) for screening - If HER2 is 2+ by IHC, FISH/CISH must be performed and must not be positive (must be a ratio of ≤ 2.2); If IHC is 0 or 1+ by institutional standards, FISH/CISH is not required; Patients with FISH/CISH in the indeterminate range (a ratio of 1.8 to 2.2) allowed provided they are not planning to receive treatment with trastuzumab.
» Recurrence Score (RS) by Oncotype DX® ≤ 25 - Submission of tissue (paraffin block from primary tumor, positive and negative lymph node block) from surgery required.
» 2. Patients with multifocal, multicentric, or synchronous bilateral breast cancers are allowed - Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant (The Oncotype DX® testing must be completed on the largest lesion); Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (Oncotype DX® testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score); Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other (The Oncotype DX® testing should be completed on the node-positive breast)
» 3. Prior diagnosis of DCIS allowed provided it was treated with mastectomy alone (no therapeutic radiation or endocrine therapy)
» 4. No inflammatory breast cancer or metastatic disease
» 5. Must have had breast-conserving surgery with planned radiotherapy or total mastectomy (with or without planned postmastectomy radiation) with clear margins within the past 56 days
» PATIENT CHARACTERISTICS:
» 1. Menopausal status: pre- or post-menopausal
» 2. Zubrod performance status 0-2
» 3. Not pregnant or nursing
» 4. Fertile patients must use an effective non-hormonal contraception method while on treatment and for ≥ 3 months after completion of protocol treatment
» 5. No other prior malignancy except adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage 0, I, or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for the past 5 years
» 6. LVEF ≥ 50% if an anthracycline-based regimen is planned
» PRIOR CONCURRENT THERAPY:
» 1. See Disease Characteristics
» 2. No prior chemotherapy or endocrine therapy for breast cancer
» 3. No prior preventive tamoxifen or raloxifene
» 4. No prior therapeutic breast radiotherapy
» 5. Not requiring concurrent chronic treatment with systemic steroids or other immunosuppressive agents
» 6. Patients randomized to either arm may also co-enroll in Phase III trials that compare local therapies or compare systemic therapies (not including chemotherapy)
» 7. Patients randomized to chemotherapy may also co-enroll in Phase III trials that compare chemotherapies

Exclusion Criteria:

» See Inclusion Criteria

Locations:


Baylor All Saints Medical Center at Fort Worth
1400 Eighth Avenue
Fort Worth , TX 76104

Baylor Medical Center at Irving
1901 N. MacArthur Blvd.
Irving , TX 75061

Lead Principal Investigator:

Oommen, Sanjay, MD (Fort Worth); Allada, Naveena, MD (Irving)



This trial is no longer available for enrollment.

Last update: December 7, 2012