Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: March 18, 2010
Last updated: July 23, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Triple-negative Breast Cancer
Drug: brostallicin
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • PFS rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • PFS rate [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: June 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: brostallicin
Given IV
Drug: cisplatin
Given IV

Detailed Description:


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.


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]).


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01091454

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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Alvaro Moreno Aspitia, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01091454     History of Changes
Other Study ID Numbers: N0937, NCCTG-N0937, CDR0000665441, NCI-2011-02016
Study First Received: March 18, 2010
Last Updated: July 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
triple-negative breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on October 02, 2015