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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 HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (SWOG S1007) (CIRB)

Conditions

Breast - Female

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2- negative breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • 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 gene amplification evaluation (e.g. FISH, CISH, etc.). Estrogen and progesterone receptor positivity must be assessed according to ASCO/CAP guidelines as either ER or PR &ge 1% positive nuclear staining. If HER2 IHC is 2+, an evaluation for gene amplification must be performed and must not be amplified, but otherwise gene amplification evaluation is not required if IHC is 0 or 1+ by institutional standards.

  • 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 (pN1mi, pN1a, pN1b or pN1c). Patients with positive sentinel node are not required to undergo full axillary lymph node dissection. This is at the discretion of the treating physician.

  • 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 (as per local institutional guidelines).

  • Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.

Exclusion Criteria:

  • 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 must not have received preventive tamoxifen or raloxifene for the prevention of breast cancer, or have received prior therapeutic ipsilateral breast radiation, unless it&rsquos partial breast irradiation for the index tumor.

  • 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, intraoperative radiation, or endocrine therapy). Radiation in the opposite breast is acceptable.

Sponsor:
Southwest Oncology Group (SWOG)
Dates:
06/13/2011
Last Updated:
Study HIC#:
1104008282