SWOG-S1207

Trial

Clinical Trial Title

SWOG-S1207

Trial Status

Open to Enrollment

Start Date

September 5, 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

Last Updated: Wednesday, September 18, 2013 01:52:58 PM