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A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients with ER, PR, HER2 Negative Breast Cancer (TNBC)

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A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients with ER, PR, HER2 Negative Breast Cancer (TNBC)

Primary- Determine the rate of pathologic complete response with treatment of liposomal doxorubicin and carboplatin in patients with ER, PR, HER2 negative breast cancer (TNBC).
Secondary-
1) Determine recurrence free survival (RFS), 2-year RFS, and overall survival (OS) after treatment with neoadjuvant liposomal doxorubicin and carboplatin followed by definitive breast surgery and then weekly paclitaxel in patients with ER, PgR, HER2 negative breast cancer.
2) Describe the mutational spectrum of tumors found in primary, untreated ER, PgR, HER2 negative breast cancer and their association with pathologic complete response to neoadjuvant doxil and carboplatin.
3) Determine functional significance of genomic landscape in predicting drug response using patient derived xenograft (PDX) and ex vivo models.

Protocol Number: 041401
Phase: Phase II
Applicable Disease Sites: Breast - Male
Breast - Female
Drugs Involved: DOXORUBICIN
CARBOPLATIN
PACLITAXEL
Principal Investigator: Nancy Chan
Scope: Local
Therapies Involved: Chemotherapy multiple agents systemic
Surgery
Radiotherapy
Participating Institutions: Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-8675.

 

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