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Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cisplatin

Radiation Therapy

Mastectomy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Locally Advanced, Neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be >= 18 years of age
Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
Adequate organ function defined as:
- Serum Creatinine <= 1.5 x upper limit of institutional normal.
- ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
- Bilirubin <= 1.5 x upper limit of institutional normal.
- Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

Exclusion Criteria:

No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.
No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
Karnofsky Performance Status of <= 70.
Patients with known history neural deficiencies (e.g. peripheral neuropathy).
Patients with a known hearing impairment (hearing loss or severe tinnitus).
Male patients

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin + Radiation + Recommended Surgery

Arm Description

Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10 Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks. Surgery (recommended) mastectomy with/without axillary lymph node dissection

Outcomes

Primary Outcome Measures

Overall Response

Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Time to Disease Progression

Time to disease progression: time from registration until objective tumor progression; does not include deaths

Overall Survival Rate (OS)

OS = Time from registration until death from any cause

Number of Participants With Surgical Complications

Number of Participants With Medical Toxicities

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.

Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response

Develop Animal Models of Triple Negative Breast Cancers

Provide Samples for the Development of the FNA Assay

Full Information

NCT ID

NCT00603408

First Posted

December 28, 2007

Last Updated

July 8, 2016

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00603408

Brief Title

Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

Official Title

Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Study was discontinued due to lack of accrual.

Study Start Date

December 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.

Detailed Description

After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy Week 2: Radiation Day 1-5: Radiation Therapy Week 3: Radiation Days 1-5: Radiation Therapy Week 4: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 2) Days 2-5: Radiation Therapy Week 5: Radiation Days 1-5: Radiation Therapy Week 6: Radiation Days 1-5: Radiation Therapy Week 7: Chemo Day 1: Cisplatin 75mg/m^2 (cycle 3) Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (cycle 4) Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m^2 & Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 every 2 weeks for 4 cycles Week 52 IVAD Removal, Bone marrow aspiration Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Locally Advanced, Neoadjuvant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin + Radiation + Recommended Surgery

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

cisplatinum

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Type

Procedure

Intervention Name(s)

Mastectomy

Intervention Description

(RECOMMENDED BUT NOT REQUIRED)

Primary Outcome Measure Information:

Title

Overall Response

Description

Time Frame

At the time of surgery (week 13)

Secondary Outcome Measure Information:

Title

Time to Disease Progression

Description

Time to disease progression: time from registration until objective tumor progression; does not include deaths

Time Frame

Until study was terminated (23.5 months)

Title

Overall Survival Rate (OS)

Description

OS = Time from registration until death from any cause

Time Frame

Until study was terminated (23.5 months)

Title

Number of Participants With Surgical Complications

Time Frame

30 days post surgery (week 17-18)

Title

Number of Participants With Medical Toxicities

Description

Time Frame

30 days post surgery (week 17-18)

Title

Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response

Time Frame

5 years

Title

Develop Animal Models of Triple Negative Breast Cancers

Time Frame

5 years

Title

Provide Samples for the Development of the FNA Assay

Time Frame

At time of IVAD placement and at time of surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be >= 18 years of age Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma. Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3). Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu Adequate organ function defined as: Serum Creatinine <= 1.5 x upper limit of institutional normal. ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal. Bilirubin <= 1.5 x upper limit of institutional normal. Normal left ventricular function (LVEF > 50%) by MUGA or ECHO. Exclusion Criteria: No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI. No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival. Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception. Karnofsky Performance Status of <= 70. Patients with known history neural deficiencies (e.g. peripheral neuropathy). Patients with a known hearing impairment (hearing loss or severe tinnitus). Male patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Aft, MD, PhD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

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17329194

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Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

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