Home
Clinical Trials
Brostallicin and Cisplatin in...

Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

Last Updated: 2018-05-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer

NCT01167192

Breast Neoplasms

TERMINATED PHASE2

Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer

NCT01928680

Metastatic Breast Cancer

UNKNOWN PHASE2

Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response

NCT00483223

Breast Cancer

COMPLETED PHASE2

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

NCT02162719

Breast Neoplasms

COMPLETED PHASE2

Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer

NCT00003041

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast cancer patients having a triple negative (estrogen receptor \[ER\]/progesterone receptor \[PR\]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.

SECONDARY OBJECTIVES:

I. To describe the confirmed tumor response rate of patients with measurable disease receiving brostallicin and cisplatin.

II. To describe the duration of response in patients with measurable disease receiving brostallicin and cisplatin.

III. To describe the 6-month progression-free survival of patients receiving brostallicin and cisplatin.

IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.

V. To evaluate the adverse event profile of the study regimen (adverse events graded using the Cancer Therapy Evaluation Program \[CTEP\] Active Version of the Common Terminology Criteria for Adverse Events \[CTCAE\]).

OUTLINE:

Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Triple-negative Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (cisplatin and brostallicin)

Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

brostallicin

Intervention Type DRUG

Given IV

cisplatin

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

brostallicin

Given IV

Intervention Type DRUG

cisplatin

Given IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered

\* NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alvaro Moreno Aspitia, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status