Expired Study
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St. Louis, Missouri 63110


Purpose:

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.


Study summary:

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/m2 (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/m2 (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/m2 (cycle 3) Week 10: Chemo Day 1:Cisplatin 75mg/m2 (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/m2 & Cyclophosphamide: 600mg/m2, every 2 weeks for 4 cycles Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m2 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


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


Study is Available At:


Original ID:

07-0913


NCT ID:

NCT00603408


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Study was discontinued due to lack of accrua


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rebecca Aft, MD, PhD
Principal Investigator
Washington University School of Medicine

Study Dates

Start Date:December 2007
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 22, 2013
First Received Date:December 28, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Effect of neoadjuvant chemoradiation therapy in disseminated cancer cells in the bone marrow and correlation to tumor response
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Develop animal models of triple negative breast cancers
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Provide samples for the development of the FNA assay
Time Frame:At time of IVAD placement and at time of surgery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Medical toxicities with cisplatin based chemoradiation
Time Frame:30 days post surgery
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Surgical complications of cisplatin based chemoradiation
Time Frame:30 days post surgery
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to disease progression
Time Frame:5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical response rate in patients with locally advanced TN tumors who received radiation combined with cisplatin
Time Frame:5 years
Safety Issues:False
Description:Obtain preliminary information on the relationship between tumor response in patients with locally advanced triple negative breast cancer treated with cisplatin based chemoradiation correlates with deficiencies in DNA repair mechanisms.

Study Interventions

Intervention Type:Drug
Name:Cisplatin
Arm Name:Cisplatin + Radiation + Recommended Surgery
Other Name:cisplatinum
Intervention Type:Radiation
Name:Radiation Therapy
Arm Name:Cisplatin + Radiation + Recommended Surgery
Intervention Type:Procedure
Name:Mastectomy
Description:(RECOMMENDED BUT NOT REQUIRED)
Arm Name:Cisplatin + Radiation + Recommended Surgery

Study Arms

Study Arm Type:Experimental
Arm Name:Cisplatin + Radiation + Recommended Surgery
Description:Cisplatin 75 mg/m2 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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. Review.
PMID:17329194
Reference Type:Reference
Citation:Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Eystein Lonning P, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74.
PMID:11553815
Reference Type:Reference
Citation:Carey, L. A., Perou, C. M., Livasy, C. A., Dressler, L. G., Cowan, D., Conway, K., Karaca, G., Troester, M. A., Tse, C. K., Edmiston, S., Deming, S. L., Geradts, J., Cheang, M. C., Nielsen, T. O., Moorman, P. G., Earp, H. S., and Millikan, R. C. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. Jama, 295: 2492-2502, 2006.
Reference Type:Reference
Citation:Turner NC, Reis-Filho JS. Basal-like breast cancer and the BRCA1 phenotype. Oncogene. 2006 Sep 25;25(43):5846-53. Review.
PMID:16998499
Reference Type:Reference
Citation:Turner, N. C., Reis-Filho, J. S., Russell, A. M., Springall, R. J., Ryder, K., Steele, D., Savage, K., Gillett, C. E., Schmitt, F. C., Ashworth, A., and Tutt, A. N. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene, 26: 2126-2132, 2007.
Reference Type:Reference
Citation: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:Reference
Citation:Bollet MA, Sigal-Zafrani B, Gambotti L, Extra JM, Meunier M, Nos C, Dendale R, Campana F, Kirova YM, Diéras 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. Epub 2006 Aug 8.
PMID:16893641
Reference Type:Reference
Citation: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.
PMID:12610186
Reference Type:Reference
Citation:Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48.
PMID:10334517
Reference Type:Reference
Citation:Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43.
PMID:10202164
Reference Type:Reference
Citation:Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. Erratum in: N Engl J Med 1999 Aug 26;341(9):708.
PMID:10202166
Reference Type:Reference
Citation:Rowinsky, E. K. and Donehower, R. C. Paclitaxel (taxol). N Engl J Med, 332: 1004-1014, 1995.
Reference Type:Reference
Citation:Rowinsky EK, Chaudhry V, Forastiere AA, Sartorius SE, Ettinger DS, Grochow LB, Lubejko BG, Cornblath DR, Donehower RC. Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J Clin Oncol. 1993 Oct;11(10):2010-20.
PMID:7692001
Reference Type:Reference
Citation:Diel IJ, Cote RJ. Bone marrow and lymph node assessment for minimal residual disease in patients with breast cancer. Cancer Treat Rev. 2000 Feb;26(1):53-65. Review.
PMID:10660491
Reference Type:Reference
Citation:Braun S, Pantel K, Müller P, Janni W, Hepp F, Kentenich CR, Gastroph S, Wischnik A, Dimpfl T, Kindermann G, Riethmüller G, Schlimok G. Cytokeratin-positive cells in the bone marrow and survival of patients with stage I, II, or III breast cancer. N Engl J Med. 2000 Feb 24;342(8):525-33. Erratum in: N Engl J Med 2000 Jul 27;343(4):308.
PMID:10684910
Reference Type:Reference
Citation:Braun S, Naume B. Circulating and disseminated tumor cells. J Clin Oncol. 2005 Mar 10;23(8):1623-6. Review. No abstract available.
PMID:15755968
Reference Type:Reference
Citation:Janni W, Rack B, Schindlbeck C, Strobl B, Rjosk D, Braun S, Sommer H, Pantel K, Gerber B, Friese K. The persistence of isolated tumor cells in bone marrow from patients with breast carcinoma predicts an increased risk for recurrence. Cancer. 2005 Mar 1;103(5):884-91.
PMID:15666325

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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