Preoperative Cisplatin in Early Stage Breast Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148694

Enrollment

Registered

2005-09-08

Start date

2004-07-31

Completion date

2010-05-31

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cisplatin, Early Stage Breast Cancer, ER Negative Breast Cancer, PR Negative Breast Cancer, HER-2 Negative Breast Cancer

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.

Detailed 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.

Interventions

DRUGCisplatin

Intravenously once every three weeks for a total of 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026