NCT00148694

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2004

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

September 7, 2005

Last Update Submit

August 29, 2016

Conditions

Breast Cancer

Keywords

CisplatinEarly Stage Breast CancerER Negative Breast CancerPR Negative Breast CancerHER-2 Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population

Study Arms (1)

Intervention single arm

EXPERIMENTAL

Cisplatin 75mg/m2 q21 days x 4 pre-surgery

Drug: Cisplatin

Interventions

CisplatinDRUG

Intravenously once every three weeks for a total of 12 weeks

Intervention single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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: 20100965RESULT

  • 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):366-375. doi: 10.1158/2159-8290.CD-11-0206. Epub 2012 Mar 22.

    PMID: 22576213RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Judy E. Garber, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

July 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2010

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)