Preoperative Cisplatin in Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148694
• Other study ID #: 04-183
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: August 29, 2016
• Start date: July 2004
• Est. completion date: May 2010

Study information

• Verified date: August 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2010
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Cisplatin
Intravenously once every three weeks for a total of 12 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Breast Cancer Research Foundation, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Birkbak NJ, Wang ZC, Kim JY, Eklund AC, Li Q, Tian R, Bowman-Colin C, Li Y, Greene-Colozzi A, Iglehart JD, Tung N, Ryan PD, Garber JE, Silver DP, Szallasi Z, Richardson AL. Telomeric allelic imbalance indicates defective DNA repair and sensitivity to DNA- — View Citation

Silver DP, Richardson AL, Eklund AC, Wang ZC, Szallasi Z, Li Q, Juul N, Leong CO, Calogrias D, Buraimoh A, Fatima A, Gelman RS, Ryan PD, Tung NM, De Nicolo A, Ganesan S, Miron A, Colin C, Sgroi DC, Ellisen LW, Winer EP, Garber JE. Efficacy of neoadjuvant — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients		TBD	No
Secondary	To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population		TBD	No