MDACC Study Summary 2007-0674 (Archived)

Study Summary
No. 2007-0674:.......Breast......Ana Gonzalez-Angulo......Breast Medical Oncology

Study Summary Title



Study Summary Number:	2007-0674

Study 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

Physician

New Patient Referral



Name:	Ana Gonzalez-Angulo	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Breast Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2817 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	Translational Breast Cancer Research Consortium

Phase of Study:	Phase II	Return Visit:	Initially, pts will visit every 2 wks until week 5. After wk 5, their next visit is 3 wks later. At this time, pt is at wk 9, visits after week 9 will be every 8 weeks.

Treatment Agents:	Cyclophosphamide Medroxyprogesterone Acetate Methotrexate	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if medroxyprogesterone acetate (MPA) given alone or with methotrexate and cyclophosphamide can help to control estrogen receptor negative (ER-) breast cancer. The safety of this drug(s) will also be studied.

Study Objectives / Outcomes

Primary Objective:

To determine the clinical benefit rate (CR + PR + SD > 6 months) of medroxyprogesterone acetate
(MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients
with refractory hormone receptor negative metastatic breast cancer.

Secondary Objective:

To evaluate the toxicity of MPA and MPA + ldoCM in this patient population.
To explore the relationship between MPA trough level and clinical benefit
To explore genetic determinants of MPA bioavailability and trough concentration
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.

Study Status Information



Study Activation / Registration Date:	08/07/2009

IRB Review and Approval Date:	02/05/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	Up to 50

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease. NOTE: Locally recurrent disease must not be amendable to surgery or radiation therapy with curative intent

2) Primary tumor must be ER negative and PR negative. Patients who are HER-2 positive and have failed herceptin.

3) Patients must be post-menopausal based on one of the following: Age>/=55 with no menses for at least 12 months; Age < 55 with no menses for at least 12 months and estradiol level in post-menopausal range according to local laboratory assessment; prior bilateral oophorectomy

4) Patients may have had any number of prior chemotherapy regimens for recurrent/metastatic disease

5) ECOG performance status of 0-2

6) Adequate organ function as evidenced by the following laboratory studies: absolute neutrophil count >/= 1000/mm^3; Platelet count >/=75,000/mm; Hemoglobin > 9 gm/dL (may be transfused); total bilirubin </= 2.0 mg/dL; AST </= 2 x upper limit of normal (</= 5 x normal in patients with known liver involvement); serum creatinine </= 2.5 mg/dL

7) Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required.

8) Patients must be able to give informed consent.

Exclusion Criteria:

1) Patients must not have extensive pleural effusion or ascites

2) Patients must not have a history of deep venous thrombosis or pulmonary embolism within the last 12 months.

3) Patients must not have received radiation therapy within 1 weeks of study entry. (The radiated area must not be the only site of measurable disease or evaluable disease.)

4) Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry. (Must be 6 weeks from prior mitomycin-C or nitrosoureas)

5) Patients who are anthracycline or Taxane na�ve or intolerant.

Links

Registration Number: NCT00577122
Study Information on Clinical Trials Registry (clinicaltrials.gov)