A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
Baylor Breast Care Center
Summary
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
Description
Neoadjuvant therapy was first introduced to improve surgical outcomes of breast cancer and to be able to assess the pathological responsiveness to therapy at the time of surgery. Over time, it became a useful experimental platform in clinical research in breast cancer, and in recent years became an important part of standard management of certain subtypes and clinical stages in breast cancer. It has been long established that patients who achieve pathologic complete response (pCR, i.e., the absence of any cancer in the tissue removed during surgery) after receiving neoadjuvant treatment have…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible. * Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines). To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \< 6; 4) Ki-67 ≥ 30%. * Tumors must be at least 2 cm by clinical exam or ul…
Interventions
- DrugPaclitaxel
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
- DrugCarboplatin
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
- DrugTrastuzumab
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
- DrugPertuzumab
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
- DrugDoxorubicin
60 mg/m2 IV administered on Day 1 of each 14-day cycle
- DrugCyclophosphamide
600 mg/m2 IV administered on Day 1 of each 14-day cycle
- Drug
Locations (2)
- Harris Health System - Smith ClinicHouston, Texas
- O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer CenterHouston, Texas