Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of breast cancer cells in women with Stage I, II, or III triple negative breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Priyanka Sharma; University of Kansas Medical Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy

• The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry.

• HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing

• No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer

• Female subjects age 18 - 70 years

• ECOG Performance Status of 0-1

• Adequate organ and marrow function as defined below:

• Leukocytes ≥ 3,000/uL

• Absolute neutrophil count ≥ 1500/uL

• Platelets ≥ 100,000/uL

• Total bilirubin ≤ 1.5mg/dL

• AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal

• Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min

• Serum albumin ≥ 3.0 g/dL

• Women of child-bearing potential must agree to use adequate contraception

• Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration

• Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation

• Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation

• Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.

• Subjects must be already enrolled in P.R.O.G.E.C.T observational registry

• Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease

• Subjects with bilateral disease are eligible if they meet other eligibility criteria.

• Neuropathy: No baseline neuropathy grade > 2

Exclusion Criteria:

• Current or anticipated use of other investigational agents

• Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer

• Subject with metastatic disease

• History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study

• Subjects with inflammatory breast cancer

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

• Subject is pregnant or nursing

• Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).

• Ejection Fraction <50% on ECHO or MUGA

• Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade ≥ 2 peripheral vascular disease