Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Condition: Triple-negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: brostallicin; cisplatin
Intervention description: Given IV; Given IV
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; triple-negative breast cancer; male breast cancer

Summary:

      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.
    

Eligibility criteria:

        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