S1007 is a clinical trial for patients with node positive (1-3 positive nodes) Hormone Receptor-Positive and HER2-Negative Breast Cancer who when tested with the Oncotype DX test are shown to have a recurrence Score (RS) of 25 or Less. Patients will be randomised to receive endocrinetherapy +/- chemotherapy.
- Conditions
- Patients with 1-3 positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer with recurrence Score (RS) of 25 or LessMedDRA version: 21.0Level: LLTClassification code 10071113Term: Node-positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000576-42-IE
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 5000
STEP 1 REGISTRATION (Oncotype DX® Screening):
1. 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 status. Estrogen and progesterone receptor positivity must be assessed according to ASCO/CAP guidelines as either ER or PR = 1% positive nuclear staining. HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER-2 equivocal is not eligible.
2. Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed. Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND). Patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c), see Section 4.0 for definitions. Patients with micrometastases as the only nodal involvement are not eligible. Patients with positive sentinel node are not required to undergo full axillary lymph node dissection. This is at the discretion of the treating physician. Axillary node evaluation is to be performed per the standard of care at each institution.
3. 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 from both invasive breast cancer and DCIS (as per local institutional guidelines). LCIS at the margins is allowed.
4. Registration of patients who have not yet undergone Oncotype DX® screening must occur no later than 56 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 15.1).
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.
5. 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.
6. Patients must have a complete history and physical examination within 28 days prior to registration.
7. Patients must have a performance status of 0-2 by Zubrod criteria (see Section 10.7).
8. Patients must be able to receive taxane and/or anthracycline based chemotherapy.
9. Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
10.Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents.
11. Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration.
12. Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen.
13. No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for
1. Patients must not have inflammatory breast cancer and must not have metastatic disease.
2. Patients with a prior diagnosis of contralateral DCIS are eligible if they underwent a mastectomy or lumpectomy with whole breast radiation. Prior partial breast irradiation, including brachytherapy, is not allowed. Patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received radiation to that breast are not eligible.
3. Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
4. Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents.
5. Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration.
6. Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen. Women of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
7. No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
8. Step 2 Registration must take place within 84 days after definitive surgery. Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method