Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the breast

- Clinical evidence of metastatic disease

- Measurable disease according to RECIST criteria

- Triple-negative breast cancer, defined as the following:

- HER2-negative (according to active ASCO/CAP guidelines)

- Estrogen receptor- and progesterone receptor-negative tumor defined as ≤ 1% by
IHC

- No evidence of active brain metastasis including leptomeningeal involvement

- CNS metastasis allowed provided it is controlled after prior surgery and/or
radiotherapy, as defined by the following criteria:

- No symptoms for ≥ 2 months

- No evidence of progression before study entry

- Corticosteroid therapy to control brain edema has been discontinued

PATIENT CHARACTERISTICS:

- Any menopausal status allowed

- ECOG performance status 0-2

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 3 times ULN (≤ 5 times ULN if the elevation is due to liver
metastases)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if the elevations are due to
liver metastases)

- Serum creatinine ≤ 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- Willing to return to NCCTG enrolling institution for treatment and follow-up

- Willing to provide blood samples for research purposes

- No other stage III or IV invasive malignancy within the past 5 years

- No pre-existing peripheral neuropathy ≥ grade 2 (according to the active version of
NCI CTCAE criteria)

- No active, unresolved infection

- No clinically significant cardiovascular or cerebrovascular disease within the past 6
months, including any of the following:

- Myocardial infarction

- Unstable angina

- NYHA class II-IV congestive heart failure

- Uncontrolled or clinically significant cardiac arrhythmia (patients with
controlled atrial fibrillation are eligible)

- Not immunocompromised (unless related to the use of corticosteroids), including known
HIV-positivity with an AIDS-defining illness

- HIV-positive patients whose CD4 count is normal and who have no history of an
AIDS-defining illness are eligible

- No concurrent uncontrolled illness including, but not limited to, psychiatric illness
or social situation, co-morbid systemic illness, or other severe concurrent disease
that, in the judgement of the investigator, would make the patient inappropriate for
study entry, would interfere significantly with the proper assessment of safety of
the prescribed treatment, would limit compliance with study requirements, or would
make it undesirable for the patient to participate in the study

- No history of allergy or hypersensitivity to the study drugs or to their excipients,
including platinum compounds (e.g., cisplatin, carboplatin)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 4 prior chemotherapy regimens in the metastatic setting

- More than 4 weeks since prior major surgery

- More than 3 weeks since prior chemotherapy or immunologic therapy

- More than 2 weeks since prior radiotherapy (except for radiotherapy to a non-target
lesion) and recovered (acute adverse events ≤ grade 1 according to the current
version of NCI CTCAE)

- Prior radiotherapy to a target lesion allowed provided there has been clear
progression of the lesion since radiotherapy was completed

- Patients who receive a single dose of radiotherapy for palliation or
radiotherapy to a non-target lesion may proceed to study registration without
waiting 2 weeks

- No concurrent treatment in another clinical study in which investigational procedures
are performed or investigational therapies are administered

- Patients may not enroll in such clinical trials while participating in this
study

- Exception may be granted for trials related to symptom management (cancer
control) that do not employ hormonal treatments or treatments that may block the
path of the targeted agents used in this study

- No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy