Clinical Trials

B-37 Resected Loco-Regional Relapse Study:

A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer

The purpose of this study is to compare the effects of standard therapy plus chemotherapy to standard therapy alone to see which treatment is better. Receiving chemotherapy at the time of diagnosis with breast cancer reduces the chance that it will come back. However, when breast cancer does return, it is not clear if more chemotherapy will help. Researchers will determine whether giving chemotherapy can decrease the chance of breast cancer from coming back again after it has already recurred once in the breast or chest area.

Patient Population:
  • Histologically verified first local and/or regional (ipsilateral axillary or internal mammary lymph node) recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment.
  • Surgical resection of the recurrence with uninvolved ("clear") margins (R0). Planned radiotherapy with >/-50 Gy for patients who had no adjuvant radiation treatment; OR
    Surgical resection with microscopically involved margins (R1): Patients are eligible only if radiation treatment with >/-50 Gy is planned.
  • No evidence of distant metastasis on standard staging examinations (x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, bone scintigraphy).
Patients will be randomized to one of the following :
  • Arm A: Patients will receive current "standard" therapy. (Standard therapy includes surgery to remove the recurrent cancer and, if the doctor believes it is appropriate, radiation therapy and/or hormonal therapy.)
  • Arm B: Patients will receive current "standard" therapy plus chemotherapy. (Standard therapy includes surgery to remove the recurrent cancer and, if the doctor believes it is appropriate, radiation therapy, and/or hormonal therapy.) The doctor will choose the type and duration of chemotherapy. The duration of chemotherapy is between 3 and 6 months depending on the choice of therapy.
 

For more information or to have a patient screened, contact the Resected Loco-Regional Relapse Study Coordinator at 713-798-1986.