This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.
Terminated
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin | Metronomic | Neoadjuvant metronomic AC followed by weekly TC |
Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a
core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic
regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2
followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical
response will be evaluated prior to surgery, the primary end-point is the pathologic
response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A
pathologic complete response (pCR) will require no histologic evidence of residual malignant
cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery
and radiation therapy will be undertaken.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Neoadjuvant metronomic AC followed by weekly TC | Experimental | Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery |
|
Inclusion Criteria:
- Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative
invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH
preferred; HER2 0 or 1+ by IHC acceptable)
- Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note:
Locally advanced T4 or inflammatory breast cancer is eligible.)
- Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable
or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam
acceptable.)
- Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
- Normal myocardial left ventricular function
- Serum creatinine < 2.0 mg/dl
- Total bilirubin and AST < 3X upper limits normal
Exclusion Criteria:
- Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a
second breast primary, patient eligible for this protocol)
- Another active cancer present
- Medical contraindications to chemotherapy or surgery
- First trimester pregnancy
- Breast feeding
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | 1) Pathologic Response |
| Time Frame: | Upon completion therapy after surgery |
| Safety Issue: | |
| Description: | Pathologic measurement post-surgery viable primary tumor mass |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Leo W. Jenkins Cancer Center |
May 26, 2021
