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A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response


This study is a Phase 2 study designed to evaluate cisplatin/carboplatin as first or second
line therapy in metastatic triple negative (ER negative, PR negative, Her2 Negative) breast
cancer and to evaluate the expression of p63/p73 as a biomarker to predict response.

- Participants will be given a cisplatin or carboplatin infusion intravenously on the
first day of each treatment cycle. Each treatment cycle will last 3 weeks. Treating
physician will select agent up to 41 patients in each cohort. Final primary endpoint
analysis will use combined cis/carbo results.

- During all treatment cycles participants will have a physical exam (including weight
and vital signs) and they will be asked general questions about their health and any
medications they may be taking, as well as specific questions about any side effects
they may be experiencing while receiving study treatment.

- During every treatment cycle participants will have standard blood tests to check blood
counts, liver and kidney function, and a blood marker for you particular type of
cancer.

- CT scans will be taken of the participants tumor every 2 to 3 cycles to assess the
response of the tumor to cisplatin.

- Participants will be in this study for as long as they tolerate the study treatment and
their disease does not get any worse.

- Participants will be required to have a sample of their original tumor sent to
Massachusetts General Hospital for correlative studies, or a sample from a metastatic
diagnostic biopsy.

- Patients with accessible tumor will be asked to provide an optional metastatic tumor
biopsy for correlative studies.


Inclusion Criteria:



- Histologically confirmed invasive breast cancer with stage IV disease, according to
AJCC 6th edition, either biopsy proven or with unequivocal evidence of metastatic
disease by physical examination or radiological study

- All tumors must be ER-, PGR- and HER2-negative

- 18 years of age or older

- Paraffin tissue block is required from the primary tumor tissue or from diagnostic
metastatic biopsy at time of relapse

- Measurable disease by RECIST

- Performance status of 0,1 or 2 by ECOG criteria

- Life expectancy greater than 12 weeks

- Normal organ and bone marrow function documented within 14 days prior to enrollment
as defined by the protocol

Exclusion Criteria:

- More than 1 prior chemotherapy for the treatment of recurrent or metastatic breast
cancer

- Prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents

- Active brain metastases or unevaluated neurological symptoms suggestive of brain
metastases

- Intercurrent illness or other major medical condition or comorbid condition that
might affect study participation

- Significant history of uncontrolled cardiac disease such as uncontrolled
hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive
heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased
ejection fraction <45%

- Renal dysfunction for which cisplatin dose would either require dose modification or
would be considered unsafe

- Pregnant or nursing women

- History or other malignancy that was not treated with curative intent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate in patients with ER/PgR/HER2 negative metastatic breast cancer receiving platinum as first or second-line therapy.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Steven Isakoff, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-412

NCT ID:

NCT00483223

Start Date:

June 2007

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • ER negative
  • PgR negative
  • HER2 negative
  • cisplatin
  • carboplatinum
  • platinum
  • p63
  • p73
  • Breast Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
UCSF San Francisco, California  941430324
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of North Carolina Chapel Hill, North Carolina  27599
Johns Hopkins University Medical Center Baltimore, Maryland  21205
University Of Alabama-Birmingham Birmingham, Alabama  35294
North Shore Medical Center Salem, Massachusetts  01970
Georgetown - Lombardi Cancer Center Washington, District of Columbia