MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial - Full Text View

Sponsored by:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00577122

Purpose

The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.

Condition	Intervention	Phase
Hormone Receptor Negative Breast Cancer Locally Recurrent Breast Cancer Metastatic Breast Cancer	Drug: Medroxyprogesterone progesterone acetate (MPA) Drug: Medroxyprogesterone Acetate with Cyclophosphamide plus Methotrexate	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Methotrexate Progesterone Medroxyprogesterone Medroxyprogesterone 17-acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial

Further study details as provided by Indiana University:

Primary Outcome Measures:

To determine the clinical benefit rate (CR + PR + SD > 6 months) of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. [ Time Frame: baseline through end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the toxicity of MPA and MPA + ldoCM in this patient population [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: Yes ]
To explore the relationship between MPA trough level and clinical benefit [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]
To explore genetic determinants of MPA bioavailability and trough concentration [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]
To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma TSP-1, change in plasma PAI-1 antigen and activity. [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.	Drug: Medroxyprogesterone progesterone acetate (MPA) 1000 mg po daily
2: Experimental Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose. Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.	Drug: Medroxyprogesterone Acetate with Cyclophosphamide plus Methotrexate Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
Primary tumor must be ER negative and PR negative
Patients must be post-menopausal
Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required

Exclusion Criteria:

Patients must not have extensive pleural effusion or ascites
Patients must not have history of DVT or pulmonary embolism w/in past 12 mo
Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
Patients must not have had radiation therapy within 1 week of study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577122

Contacts

Contact: LaTrice Vaughn, RN	317-278-3730	lgvaughn@iupui.edu
Contact: Kathy Miller, MD	317-274-1690	kathmill@iupui.edu

Locations

United States, California
University of California, San Francisco Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Jill Grothusen, RN 415-353-7517 grothusenj@cc.ucsf.edu
Contact: Hope Rugo, MD hrugo@medicine.ucsf.edu
Principal Investigator: Hope Rugo, MD
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: LaTrice Vaughn, RN 317-278-3730 lgvaughn@iupui.edu
Contact: Kathy Miller, MD 317-274-1690 kathmill@iupui.edu
Principal Investigator: Kathy Miller, MD
United States, North Carolina
University of North Carolina, Lineberger Comprehensive Cancer Center	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Nancy Pope, RN 919-966-4432 Nancy_Pope@med.unc.edu
Contact: Lisa Carey, MD 919-843-7719 Lisa_Carey@med.unc.edu
Principal Investigator: Lisa Carey, MD

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator:

Kathy Miller, MD

IU Simon Cancer Center

More Information

IU Simon Cancer Center 'Find a Clinical Trial' This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University Simon Cancer Center ( Kathy Miller, MD/ Principal Investigator )
Study ID Numbers:	0607-18 IUCRO-0154
Study First Received:	December 18, 2007
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00577122
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Medroxyprogesterone progesterone acetate (MPA)
Cyclophosphamide plus Methotrexate

Study placed in the following topic categories:

Folic Acid
Medroxyprogesterone 17-Acetate
Progesterone
Skin Diseases
Methotrexate

Breast Neoplasms
Medroxyprogesterone
Cyclophosphamide
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Neoplasms by Site
Progestins

Therapeutic Uses
Abortifacient Agents
Contraceptives, Oral, Synthetic
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on January 16, 2009