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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, FL
Clinical Trial Details
Research Study Summary
S1007, "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."
- Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, as determined by IHC or non-amplified FISH for screening. Estrogen and progesterone positivity must be assessed according to ASCO/CAP guidelines (assays are considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal [normal epithelial elements] and external controls). See http://www.asco.org/guidelines/erpr. If HER2 IHC is 2+, FISH must be performed and must not be positive (must be a ratio of ≤ 2.2), but otherwise FISH is not required if IHC is 0 or 1+ by institutional standards. Patients with FISH in the indeterminate range (a ratio of 1.8 to 2.2) are eligible for the study only if they are not planning to receive treatment with trastuzumab.
- Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND). Patients must have at least one, but no more than three known positive lymph nodes (pN1mi, pN1a, pN1b or pN1c), see Section 4.0 for definitions. Axillary node evaluation is to be performed per the standard of care at each insititution.
- Patients must not have inflammatory breast cancer and must not have metastatic disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation or endocrine therapy).
- Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). Patients must have clear margins.
- Registration of patients who have not yet undergone Oncotype DX® screening must occur no sooner than 28 days and no later than 56 days after definitive surgery. (For all patients, Step 2 Registration must occur within 84 days after definitive surgery.) If the Oncotype DX® Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value. A representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX® Breast Cancer Assay which will be performed according to the standard commercial process (see Section 15.2).
(contd.) If the Oncotype DX® Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration. If the Oncotype
DX® Recurrence Score is already known and is greater than 25, the patient is ineligible.
- Patients must be females ≥ 18 years of age. As the Oncotype DX® Recurrence Score has not been validated in men with breast cancer, men are not eligible for this study.
- Patients must have a performance status of 0-2 by Zubrod criteria (see Section 10.7).
- Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
- Patients must not require chronic treatment with systemic steroids or other immunosuppressive agents.
- Patients must not have received preventive tamoxifen or raloxifene, or have received prior therapeutic breast radiation.
- Pregnant or nursing women are not eligible because of the risk of fetal harm. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from this treatment regimen. Women of reproductive potential who are sexually active must agree to use an effective non-hormonal contraceptive method while on treatment and for at least 3 months after completion of protocol treatment.
- No other prior malignancy is allowed except for the following: 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 5 years.
- Patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy. Patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy.
- Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX® screening must have completed the S1007 Health-Related Quality of Life Questionnaire: Enrollment form within 14 days prior to Step 1 Registration.
- Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX® Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study form as outlined in Section 5.19).
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. For Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX® Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form. For both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form.
- At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.
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Date Last Changed:
July 19, 2013
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