Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Every patient will receive eribulin and carboplatin. Each cycle is 21 days (or 3 weeks). Eribulin and carboplatin will be given intravenously on days 1 and 8 of each cycle.

Eribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines.

Level 1: 0.9 mg/m\^2; Level 2: 1.1 mg/m\^2; Level 3: 1.4 mg/m\^2

Eribulin

Carboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25).

Heather Han, M.D.

This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Some cells stop working like they should and become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to normal body organs. Eribulin and carboplatin have both been approved by United States Food and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of these two drugs and the safest dose of eribulin to use is experimental.

A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients

A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer

The primary objective of the trial is to determine the safety and tolerability of eribulin mesylate and carboplatin in combination. The primary safety endpoint is dose limiting toxicity (DLT). The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 30%. Planned doses for evaluation of eribulin mesylate include 0.9, 1.1, and 1.4 mg/m\^2.

Response rate will be provided for the subjects in the study overall. Response rates and 95% confidence intervals will be provided. Eribulin mesylate pharmacokinetic variables: peak concentration (CPeak) and trough plasma concentrations (Ctrough) will be calculated as appropriate and summary statistics will be provided.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients	NCT01795586	Breast Cancer	Eribulin Carboplatin	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients	NCT01795586	Breast Cancer	Eribulin Carboplatin	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for cytologically confirmed