Clinical trial NCT00603408: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Locally Advanced
Neoadjuvant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Overall Response
timeFrame: At the time of surgery (week 13)
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: Until study was terminated (23.5 months)
measure: Overall Survival Rate (OS)
timeFrame: Until study was terminated (23.5 months)
measure: Number of Participants With Surgical Complications
timeFrame: 30 days post surgery (week 17-18)
measure: Number of Participants With Medical Toxicities
timeFrame: 30 days post surgery (week 17-18)
measure: Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response
timeFrame: 5 years
measure: Develop Animal Models of Triple Negative Breast Cancers
timeFrame: 5 years
measure: Provide Samples for the Development of the FNA Assay
timeFrame: At time of IVAD placement and at time of surgery
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rebecca Aft, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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