Trials / Active Not Recruiting

Active Not RecruitingNCT02315196

Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer

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

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 62 (actual)

Sponsor: Rutgers, The State University of New Jersey · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative). Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel may be an effective treatment for breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the rate of pathologic complete response with treatment of liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) and carboplatin in patients with estrogen receptor (ER), progesterone receptor (PR), HER2 negative breast cancer (triple negative breast cancer \[TNBC\]). SECONDARY OBJECTIVES: I. To determine the 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, progesterone receptor (PgR), HER2 negative breast cancer. II. To 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 pegylated liposomal doxorubicin hydrochloride (doxil) and carboplatin. III. To determine functional significance of genomic landscape in predicting drug response using patient derived xenograft (PDX) and ex vivo models. OUTLINE: NEOADJUVANT: Patients receive pegylated liposomal doxorubicin hydrochloride\* intravenously (IV) over 90 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. ADJUVANT: Patients undergo definitive surgery at the discretion of the treating physician. Patients then receive paclitaxel IV over 60 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. \*NOTE: If there is a shortage of pegylated liposomal doxorubicin hydrochloride, patients receive epirubicin hydrochloride IV over 15-20 minutes on day 1. After completion of study treatment, patients are followed up every 6 months for up to 20 years.

Conditions

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin hydrochloride	Given IV
DRUG	epirubicin hydrochloride	Given IV
DRUG	carboplatin	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo definitive surgery
DRUG	paclitaxel	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

Start date: 2015-02-25
Primary completion: 2021-02-08
Completion: 2041-07-01
First posted: 2014-12-11
Last updated: 2023-03-29
Results posted: 2023-03-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02315196. Inclusion in this directory is not an endorsement.