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SWOG S1418

Trial

Clinical Trial Title

SWOG S1418

Trial Status

Open to Enrollment

Start Date

October 15, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Eligibility Criteria

  • Patients must have histologically confirmed ER-, PR- and HER2-negative (triple-negative, TNBC) with residual invasive breast cancer, after completion of neoadjuvant chemotherapy. Residual disease must be ≥ 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam
  • Patients must be women or men ≥ 18 years of age
  • Patients must have Zubrod Performance Status ≤ 2
  • Patients must not have metastatic disease
  • It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response. Patients must have a complete axillary lymph node dissection after neoadjuvant chemotherapy in the following situations
  •     Patients had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)
  •     Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy
  • Patients must have had neoadjuvant chemotherapy followed by surgery. The recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by NCCN guidelines for triple negative breast cancer
  • Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration after completion of surgery at the discretion of the treating physician
  • Patients must have completed their final breast surgery
  • Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs
  • Patients must not have an active infection requiring systemic therapy
  • No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Thursday, December 28, 2017 12:53:07 PM