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SWOG S1207

Trial

Clinical Trial Title

SWOG S1207

Trial Status

Open to Enrollment

Start Date

March 1, 2013

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer

Eligibility Criteria

SWOG S1207: Breast Cancer Trial 

Choice of endocrine therapy dependent upon menopausal status and patient/physician preference

ENDOCRINE TREATMENT SHOULD BE AT LEAST 5 YEARS BUT CAN BE EXTENDED

Switching from one therapy to another is allowed

Inclusion Criteria

ü  ER and/or PR positive

ü  HER2 negative

ü  High Risk based one of the following:

  • Node negative, tumor 2cm, Oncotype RS > 25, and completed adjuvant chemo
  • 1-3 pathologically positive nodes, Oncotype RS > 25, and completed adjuvant chemo
  • 4+ pathologically positive nodes and completed adjuvant chemo
  • 4+ pathologically positive nodes (before or after) neoadjuvant chemotherapy

ü  Must have completed either adjuvant or neoadjuvant chemotherapy

ü  Multifocal, multicentric, and synchronous bilateral cancer allowed

ü  Lumpectomy patients MUST receive whole breast radiation

ü  Patients with 4 lymph nodes positive MUST receive breast/chest wall and nodal basin RT

ü  Patients with 4 lymph nodes positive MUST have axillary lymph node dissection

 

Exclusion Criteria

  • Inflammatory breast cancer
  • Metastatic breast cancer
  • No prior malignancy unless disease free for at least 5 years
  • Use of chronic, systemic treatment with corticosteroids or other immunosuppressive agents (topical or inhaled allowed).

 

IRB Number

IRB00009228

Notes

Sponsored by: SWOG Southwest Oncology Group

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, May 31, 2017 10:52:26 AM