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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Leo W. Jenkins Cancer Center
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT00542191
First received: October 9, 2007
Last updated: August 26, 2013
Last verified: August 2013
  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.


Condition Intervention Phase
Breast Cancer
Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin
Procedure: Definitive Surgery
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • 1) Pathologic response [ Time Frame: within 3 weeks of completing neoadjuvant chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Clinical response 2) Disease free survival (DFS) 3) Overall Survival (OS) [ Time Frame: Ongoing clinical surveillance follow-up assessing Disease Free and Overall Survival ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: July 2007
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm study; taxol, XRT, gemzar and carbo Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin
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
Procedure: Definitive Surgery
Standard of care definitive surgery as determined by medical provider
Radiation: Radiotherapy
Standard of care RADIATION THERAPY as indicated

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542191

Contacts
Contact: Paul Walker, MD 252-744-1888 walkerp@ecu.edu
Contact: Susan Eubanks, RN, OCN 252-744-1015 eubankss@ecu.edu

Locations
United States, North Carolina
Brody School of Medicine at East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Investigators
Principal Investigator: Paul Walker, MD Brody School of Medicine at East Carolina University
  More Information

Publications:
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)
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)
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)
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)
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)
Ellis GK, Barlow WE, Russell CA, et al: SWOG 0012, a randomized phase III comparison of standard doxorubicin and cyclophosphamide followed by weekly paclitaxel versus weekly doxorubicin and daily oral cyclophosphamide plus G-CSF followed by weekly paclitaxel as neoadjuvant therapy for inflammatory and locally advanced breast cancer. J Clin Oncol 2006 (suppl; abstr 537)

Responsible Party: Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT00542191     History of Changes
Other Study ID Numbers: LJCC 07-03
Study First Received: October 9, 2007
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Leo W. Jenkins Cancer Center:
Triple negative (ER/PR negative; HER2 negative)

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Carboplatin
Cyclophosphamide
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014