Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer

NCT ID: NCT01167192

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to determine whether platinum-based chemotherapy (either cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective in improving response to treatment in triple negative breast cancer patients. This treatment is being studied in this type of breast cancer because it does not respond well to commonly used treatments such as tamoxifen or herceptin.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation

Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.

Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.

Recommended mastectomy

Recommended adjuvant chemotherapy

-doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m2 for 14 days for 4 cycles)

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Radiation therapy

Intervention Type: RADIATION

Mastectomy (recommended but not mandatory)

Intervention Type: PROCEDURE

Interventions

Cisplatin

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Radiation therapy

Intervention Type: RADIATION

Mastectomy (recommended but not mandatory)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient must be > or = 18 years of age
• Patient must be female
• Patient must have primary invasive ductal breast adenocarcinoma that either:

1. is newly diagnosed, without previous systemic treatment OR

2. has failed to respond to < or = 4 cycles of neoadjuvant anthracycline based therapy as assessed by clinical exam or imaging studies (mammogram, ultrasound or breast MRI).

• Patient's tumor must be classified as clinically stage T2, T3, or T4 with any N (NX, N0, N1, N2, or N3) prior to any neoadjuvant treatment.
• Patient must have an ECOG Performance Status of < or = 1.
• Patient must have adequate organ function defined as:

1. Renal Function:

1. CrCl ≥ 60 ml/min for patients receiving cisplatin

2. CrCl ≥ 30 ml/min for patients receiving carboplatin.

2. Liver Function:

1. ALT, AST, ALK Phos < or = 1.5 x upper limit of institutional normal.

2. Bilirubin < or = 1.5 x upper limit of institutional normal.

3. Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

4. Hematologic:

1. Absolute Neutrophil Count > or = 1500/mcl

2. Platelets > or = 100,000/mcl

3. Hemoglobin > or = 8.0 g/dl

• Patient must be able and willing to sign informed consent document.

Exclusion Criteria

• Patient must not have evidence of distant metastasis present by CT, bone scan, or PET-CT. 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 at the discretion of the treating physician.
• Patients having received neoadjuvant anthracycline based therapy must undergo restaging to exclude distant metastases prior to enrollment.
• Patient must not have had any 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.
• Patient's tumor must not express the following biomarkers or must have Allred score < 4 for: estrogen receptor, progesterone receptor, and is not Her2/neu amplified.
• Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
• Patient must have > or = grade 2 peripheral neuropathy.
• Patient must have a known hearing impairment (hearing loss or severe tinnitus). Hearing test will be performed at the discretion of the treating physician.
• Patient must not have been previously treated with cisplatin or carboplatin for any condition.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Aft, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.

Reference Type: BACKGROUND

PMID: 17329194 (View on PubMed)

Garber, J., Richardson, A., Harris, L., Miron, A., Silver, D., Golshan, M., Ryan, P., Ganesan, S., Wang, Z., Clarke, K., Inglehart, J., and Winer, E. Neoadjuvant cisplatin in triple negative breast cancer. SABCS, 2006.

Reference Type: BACKGROUND

Bollet MA, Sigal-Zafrani B, Gambotti L, Extra JM, Meunier M, Nos C, Dendale R, Campana F, Kirova YM, Dieras V, Fourquet A; Institut Curie Breast Cancer Study Group. Pathological response to preoperative concurrent chemo-radiotherapy for breast cancer: results of a phase II study. Eur J Cancer. 2006 Sep;42(14):2286-95. doi: 10.1016/j.ejca.2006.03.026. Epub 2006 Aug 8.

Reference Type: BACKGROUND

PMID: 16893641 (View on PubMed)

Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.

Reference Type: BACKGROUND

PMID: 12610186 (View on PubMed)

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201310089

Identifier Type: -

Identifier Source: org_study_id