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Neoadjuvant Carboplatin and Docetaxel in TNBC

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Triple-negative Breast Cancer

Intervention: Paclitaxel (Drug); Carboplatin (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Kansas

Official(s) and/or principal investigator(s):
Priyanka Sharma, MD, Principal Investigator, Affiliation: University of Kansas

Overall contact:
Priyanka Sharma, MD, Phone: 913-588-2069, Email: psharma2@kumc.edu

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.

Clinical Details

Official title: Randomized, Open Label, Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by AC in Stage I-III Triple-negative Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathological complete response rates

Secondary outcome: Minimal residual disease rates

Detailed description: Sporadic and germline BRCA mutation associated triple-negative breast cancer share several pathological and molecular similarities which have led to the exploration of DNA damaging agents like platinum compounds in patients with triple-negative breast cancer. Recent studies demonstrate that addition of neoadjuvant carboplatin to doxorubicin/cyclophosphamide/taxane-based chemotherapy improves pathological complete response in patients with stage I-III triple-negative breast cancer but also increase toxicity. A recent study reported encouraging pathological complete response rates with a non-anthracycline carboplatin plus docetaxel neoadjuvant chemotherapy regimen in a cohort of 49 triple negative breast cancer patients. This chemotherapy regimen of carboplatin plus docetaxel yielded an overall pathological complete response rate of 65% in unselected triple-negative breast cancer with pathological complete response rates of 61% in sporadic and 77% in germline BRCA-associated triple-negative breast cancer. The chemotherapy regimen of carboplatin/docetaxel is well tolerated and should be studied further and compared with regimens that add carboplatin to the standard anthracycline/taxane containing regimens. This is the basis for the proposed randomized neoadjuvant phase II study to further estimate and compare pathological complete response rates of carboplatin plus docetaxel x 6 cycles to carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide x 4 cycles in stage I-III triple negative-breast cancer.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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 .

- Subjects in Arm A 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

- 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

Locations and Contacts

Priyanka Sharma, MD, Phone: 913-588-2069, Email: psharma2@kumc.edu

University of Kansas Cancer Center - CRC, Fairway, Kansas 66205, United States; Recruiting
Kerry Hepler, RN, Phone: 913-945-7552, Email: khepler@kumc.edu
Stella Baccaray, Phone: 913-588-2437, Email: sbaccaray@kumc.edu

Hays Medical Center, Hays, Kansas 67601, United States; Not yet recruiting
Josette Klaus, RN, Phone: 785-623-5761, Email: josette.klaus@haysmed.com
Shawn Mulkey, RN, Phone: 785-623-5774, Email: shawn.mulkey@hays.com

University of Kansas Cancer Center - Westwood, Westwood, Kansas 66205, United States; Recruiting
Kerry Hepler, RN, Phone: 913-945-7552, Email: khepler@kumc.edu
Stella Baccaray, Phone: 913-588-2437, Email: sbaccaray@kumc.edu

Truman Medical Center, Kansas City, Missouri 64108, United States; Not yet recruiting
Denise Sharp, RN, Phone: 816-404-4045, Email: Denise.Sharp@tmcmed.org
Nikki Malomo, Phone: 816-404-4093, Email: nikki.malomo@tmc.med.org

Additional Information

Starting date: July 2015
Last updated: July 9, 2015

Page last updated: August 23, 2015

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