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A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer


Before starting treatment patients will undergo placement of a clip into the tumor bed so
the surgeon can locate the site of the tumor at the time of surgery.

Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles
or 12 weeks of treatment.

After completion of cisplatin, patients will undergo surgery to remove any tumor that
remains and to assess the tissue to see if tumor cells remain in the breast.

Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see
whether we can identify tumors that will ultimately respond to cisplatin with a rapid
evaluation.

Patients will receive study treatment for approximately 12 weeks unless unacceptable
toxicity occurs. After surgery patients will receive standard adjuvant therapy based on
discussion with their physician. Follow-up progress will occur for several years.


Inclusion Criteria:



- All tumors must be ER-, PR- and HER-2 negative.

- Age > 18 years

- ECOG performance status of less than or equal to 1

- Absolute neutrophil count (ANC) > 1,500/mm3

- Hemoglobin > 9mm/dl

- Platelets > 100,000/mm3

- Creatinine < 1.5mg/dl

- Glucose < 200mg/dl

- Bilirubin < 1.5 x upper limit of normal (ULN)

- SGOT < 3.0 x ULN

Exclusion Criteria:

- Prior chemotherapy treatment

- Pregnant or breast-feeding women

- History of serious illness, medical or psychiatric condition requiring medical
management

- Uncontrolled infection

- Renal dysfunction

- Active or severe cardiovascular or pulmonary disease

- Peripheral neuropathy of any etiology that exceeds grade 1

- Prior history of malignancy

- Uncontrolled diabetes

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Judy E. Garber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

04-183

NCT ID:

NCT00148694

Start Date:

July 2004

Completion Date:

May 2010

Related Keywords:

  • Breast Cancer
  • Cisplatin
  • Early Stage Breast Cancer
  • ER Negative Breast Cancer
  • PR Negative Breast Cancer
  • HER-2 Negative Breast Cancer
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617