Know Cancer

or
forgot password

A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Cancer of the Breast, Neoplasms, Breast

Thank you

Trial Information

A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies


Inclusion Criteria:



- Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer
metastatic breast cancer

- Clinically determined evaluable disease

- Post-menopausal woman

- Previous clinical benefit from prior anti-estrogen therapies and subsequent failure
of at least 2 prior endocrine therapies.

- May have had chemotherapy for adjuvant &/or metastatic disease.

- May have had radiation therapy but not to the only site of disease.

- Ecog performance status
- Life expectancy of > 6 months

Exclusion Criteria:

- Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical
trial

- Brain metastasis

- Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary
embolus

- Current vaginal bleeding

- Hypercalcemia or hypocalcemia

- History of or active hepatic adenoma

- No other malignancies within the past 5 years with the exception of curatively
treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the
cervix

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mary Daly, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

FER-BR-030

NCT ID:

NCT00661531

Start Date:

April 2008

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Cancer of the Breast
  • Neoplasms, Breast
  • Breast cancer
  • Metastatic breast cancer
  • ER positive breast cancer
  • Hormonal therapy
  • Breast Neoplasms
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cooper Cancer InstituteCamden, New Jersey  08103
Georgetown University Medical CenterWashington, District of Columbia  20007