Expired Study
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Greenville, North Carolina 27834


Purpose:

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.


Study summary:

Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.


Criteria:

Inclusion Criteria: - Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable) - Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.) - Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.) - Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3 - Normal myocardial left ventricular function - Serum creatinine < 2.0 mg/dl - Total bilirubin and AST < 3X upper limits normal Exclusion Criteria: - Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol) - Another active cancer present - Medical contraindications to chemotherapy or surgery - First trimester pregnancy - Breast feeding


Study is Available At:


Original ID:

LJCC 07-03


NCT ID:

NCT00542191


Secondary ID:


Study Acronym:


Brief Title:

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer


Official Title:

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

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

Study Source:

Leo W. Jenkins Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Enrollment Completed


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paul Walker, MD
Principal Investigator
Brody School of Medicine at East Carolina University

Study Dates

Start Date:July 2007
Completion Date:August 2, 2016
Completion Type:Actual
Primary Completion Date:August 2, 2016
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:August 19, 2019
First Received Date:October 9, 2007
First Results Date:March 13, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:1) Pathologic Response
Time Frame:Upon completion therapy after surgery
Safety Issues:False
Description:Pathologic measurement post-surgery viable primary tumor mass

Study Interventions

Intervention Type:Drug
Name:Doxorubicin / Cyclophosphamide / Paclitaxel / Carb
Description:DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks
Arm Name:Neoadjuvant metronomic AC followed by weekly TC
Other Name:Metronomic
Intervention Type:Procedure
Name:Definitive Surgery
Description:Standard of care definitive surgery as determined by medical provider
Arm Name:Neoadjuvant metronomic AC followed by weekly TC
Intervention Type:Radiation
Name:Radiotherapy
Description:Standard of care RADIATION THERAPY as indicated
Arm Name:Neoadjuvant metronomic AC followed by weekly TC

Study Arms

Study Arm Type:Experimental
Arm Name:Neoadjuvant metronomic AC followed by weekly TC
Description:Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Leo W. Jenkins Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Ellis GK, Barlow WE, Gralow JR, Hortobagyi GN, Russell CA, Royce ME, Perez EA, Lew D, Livingston RB. Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer: SWOG 0012. J Clin Oncol. 2011 Mar 10;29(8):1014-21. doi: 10.1200/JCO.2009.27.6543. Epub 2011 Jan 10.
PMID:21220618
Reference Type:Reference
Citation:Ellis GK, Livingston RB, Rinn K, et al: Pilot adjuvant study: 12 weeks of dose dense doxorubicin with scheduled G-CSF support followed by 4 cycles of docetaxel. J Clin Oncol 2003 (suppl; abstr 148)
Reference Type:Reference
Citation:Hudis C, Citron M, Berry D, et al: Five-year follow-up of INT C9741: dose-dense chemotherapy is safe and effective. San Antonio Breast Cancer Symposium. San Antonio, TX, 2005 (abstr 41)
Reference Type:Reference
Citation:Jacquemier J, Penault-Llorca F, Mnif H, et al: Identification of a basal-like subtype and comparative effect of epirubicin-based chemotherapy and sequential epirubicin followed by docetaxel chemotherapy in the PACS 01 breast cancer trial: 33 markers studied on tissue microarrays (TMA). J Clin Oncol 2006 (suppl; abstr 509)
Reference Type:Reference
Citation:Carey LA, Dees EC, Sawyer L, et al: The triple negative paradox: Primary tumor chemosensitivity of the basal-like breast cancer (BBC) phenotype. San Antonio Breast Cancer Symposium. San Antonio, TX, 2004 (abstr 1023)
Reference Type:Reference
Citation:Rouzier R, Anderson K, Hess KR, et al: Basal and luminal types of breast cancer defined by gene expression patterns respond differently to neoadjuvant chemotherapy. San Antonio Breast Cancer Symposium. San Antonio, TX, 2004 (abstr 1023)
Reference Type:Reference
Citation:Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005 Jun 1;23(16):3676-85. Epub 2005 Feb 28.
PMID:15738535
Reference Type:Reference
Citation:Hennessy BT, Hortobagyi GN, Rouzier R, Kuerer H, Sneige N, Buzdar AU, Kau SW, Fornage B, Sahin A, Broglio K, Singletary SE, Valero V. Outcome after pathologic complete eradication of cytologically proven breast cancer axillary node metastases following primary chemotherapy. J Clin Oncol. 2005 Dec 20;23(36):9304-11.
PMID:16361629
Reference Type:Reference
Citation:Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. Erratum in: J Clin Oncol. 2006 Jul 1;24(19):3221.
PMID:16622270
Reference Type:Reference
Citation:Perez EA, Suman VJ, Rowland KM, Ingle JN, Salim M, Loprinzi CL, Flynn PJ, Mailliard JA, Kardinal CG, Krook JE, Thrower AR, Visscher DW, Jenkins RB. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005 Dec;6(5):425-32.
PMID:16381626
Reference Type:Reference
Citation:Robert N, Leyland-Jones B, Asmar L, Belt R, Ilegbodu D, Loesch D, Raju R, Valentine E, Sayre R, Cobleigh M, Albain K, McCullough C, Fuchs L, Slamon D. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2786-92.
PMID:16782917
Reference Type:Reference
Citation:Kerbel RS, Klement G, Pritchard KI, Kamen B. Continuous low-dose anti-angiogenic/ metronomic chemotherapy: from the research laboratory into the oncology clinic. Ann Oncol. 2002 Jan;13(1):12-5.
PMID:11863092
Reference Type:Reference
Citation:Kennedy RD, Quinn JE, Mullan PB, Johnston PG, Harkin DP. The role of BRCA1 in the cellular response to chemotherapy. J Natl Cancer Inst. 2004 Nov 17;96(22):1659-68. Review.
PMID:15547178
Reference Type:Reference
Citation:Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ, Martino S, Perez EA, Muss HB, Norton L, Hudis C, Winer EP. Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA. 2006 Apr 12;295(14):1658-67. Erratum in: JAMA. 2006 May 24;295(20):2356.
PMID:16609087
Reference Type:Reference
Citation:Carey LA, Perou CM, Livasy CA, Dressler LG, Cowan D, Conway K, Karaca G, Troester MA, Tse CK, Edmiston S, Deming SL, Geradts J, Cheang MC, Nielsen TO, Moorman PG, Earp HS, Millikan RC. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA. 2006 Jun 7;295(21):2492-502.
PMID:16757721
Reference Type:Reference
Citation:Turner N, Tutt A, Ashworth A. Hallmarks of 'BRCAness' in sporadic cancers. Nat Rev Cancer. 2004 Oct;4(10):814-9. doi: 10.1038/nrc1457. Review.
PMID:15510162
Reference Type:Reference
Citation:Chang HY, Nuyten DS, Sneddon JB, Hastie T, Tibshirani R, Sørlie T, Dai H, He YD, van't Veer LJ, Bartelink H, van de Rijn M, Brown PO, van de Vijver MJ. Robustness, scalability, and integration of a wound-response gene expression signature in predicting breast cancer survival. Proc Natl Acad Sci U S A. 2005 Mar 8;102(10):3738-43. Epub 2005 Feb 8.
PMID:15701700
Reference Type:Reference
Citation:Nielsen TO, Hsu FD, Jensen K, Cheang M, Karaca G, Hu Z, Hernandez-Boussard T, Livasy C, Cowan D, Dressler L, Akslen LA, Ragaz J, Gown AM, Gilks CB, van de Rijn M, Perou CM. Immunohistochemical and clinical characterization of the basal-like subtype of invasive breast carcinoma. Clin Cancer Res. 2004 Aug 15;10(16):5367-74.
PMID:15328174
Reference Type:Reference
Citation:Brenton JD, Carey LA, Ahmed AA, Caldas C. Molecular classification and molecular forecasting of breast cancer: ready for clinical application? J Clin Oncol. 2005 Oct 10;23(29):7350-60. Epub 2005 Sep 6. Review.
PMID:16145060
Reference Type:Reference
Citation:Sotiriou C, Neo SY, McShane LM, Korn EL, Long PM, Jazaeri A, Martiat P, Fox SB, Harris AL, Liu ET. Breast cancer classification and prognosis based on gene expression profiles from a population-based study. Proc Natl Acad Sci U S A. 2003 Sep 2;100(18):10393-8. Epub 2003 Aug 13.
PMID:12917485
Reference Type:Reference
Citation:Perou CM, Sørlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lønning PE, Børresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52.
PMID:10963602
Reference Type:Reference
Citation:Sørlie 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, Lønning PE, Børresen-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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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