Boston, Massachusetts 02115

  • Breast Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

04-183


NCT ID:

NCT00148694


Secondary ID:


Study Acronym:


Brief Title:

Preoperative Cisplatin in Early Stage Breast Cancer


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Judy E. Garber, MD
Principal Investigator
Dana-Farber Cancer Institute

Study Dates

Start Date:July 2004
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 29, 2016
First Received Date:September 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients
Time Frame:TBD
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population
Time Frame:TBD
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Cisplatin
Description:Intravenously once every three weeks for a total of 12 weeks
Arm Name:Intervention single arm

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention single arm
Description:Cisplatin 75mg/m2 q21 days x 4 pre-surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Beth Israel Deaconess Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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 Cisplatin in triple-negative breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1145-53. doi: 10.1200/JCO.2009.22.4725. Epub 2010 Jan 25.
PMID:20100965
Reference Type:Results Reference
Citation: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-damaging agents. Cancer Discov. 2012 Apr;2(4):366-75. doi: 10.1158/2159-8290.CD-11-0206. Epub 2012 Mar 22. Erratum in: Cancer Discov. 2013 Aug;3(8):952.
PMID:22576213

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.