Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Triple-negative Breast Cancer

In brief

This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.

Key facts

Study ID

NCT01091454

Run by

Alliance for Clinical Trials in Oncology

People needed

48

Starts

2010-06-01

Expected to finish

2014-11-01

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease
• Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER- (defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)
• 0 to 4 prior chemotherapy regimens in the metastatic setting
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
• Hemoglobin >= 10.0 g/dL
• Absolute neutrophil count (ANC) >= 1500/mm\^3
• Platelet count >= 100,000/mL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum creatinine =< 1.5 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases
• Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are due to liver metastases
• Electrocardiogram (EKG) completed =< 15 days prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
• Life expectancy > 3 months
• Has written informed consent
• Willingness to return to NCCTG enrolling institution for treatment and follow-up
• Patient willing to provide blood samples for research purposes

You may not qualify if…

• HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines
• Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)
• Any of the following
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs
• Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration
• Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)
• Major surgery =< 4 weeks prior to registration
• Chemotherapy or immunologic therapy =< 3 weeks prior to registration
• Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only
• NOTES:
• Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
• If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks
• Acute adverse events from radiation must have resolved to =< grade 1 (according to the CTEP active version of the CTCAE)
• Evidence of active brain metastasis including leptomeningeal involvement
• NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued
• History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)
• Active, unresolved infection
• Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial
• Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:
• Myocardial infarction
• Unstable angina
• New York Heart Association (NYHA) class II or greater congestive heart failure
• Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)

Where it is running

• Cancer Center of Kansas, PA - Kingman — Kingman, Kansas, United States
• Lawrence Memorial Hospital — Lawrence, Kansas, United States
• Cancer Center of Kansas, PA - Liberal — Liberal, Kansas, United States
• Cancer Center of Kansas, PA - Newton — Newton, Kansas, United States
• Cancer Center of Kansas, PA - Parsons — Parsons, Kansas, United States
• Cancer Center of Kansas, PA - Pratt — Pratt, Kansas, United States
• Cancer Center of Kansas, PA - Salina — Salina, Kansas, United States
• Cancer Center of Kansas, PA - Wellington — Wellington, Kansas, United States
• Associates in Womens Health, PA - North Review — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Medical Arts Tower — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Wichita — Wichita, Kansas, United States
• CCOP - Wichita — Wichita, Kansas, United States
• Via Christi Cancer Center at Via Christi Regional Medical Center — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Winfield — Winfield, Kansas, United States
• Hickman Cancer Center at Bixby Medical Center — Adrian, Michigan, United States
• Saint Joseph Mercy Cancer Center — Ann Arbor, Michigan, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Battle Creek Health System Cancer Care Center — Battle Creek, Michigan, United States
• Oakwood Cancer Center at Oakwood Hospital and Medical Center — Dearborn, Michigan, United States
• Green Bay Oncology, Limited - Escanaba — Escanaba, Michigan, United States
• Genesys Hurley Cancer Institute — Flint, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Butterworth Hospital at Spectrum Health — Grand Rapids, Michigan, United States
• CCOP - Grand Rapids — Grand Rapids, Michigan, United States
• Cancer Center of Kansas-Independence — Independence, Kansas, United States

Full record on ClinicalTrials.gov

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