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Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors. A Phase II Study to Identify Molecular Predictors for Hormone Responsiveness and/or Resistance.


Phase 2
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

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Trial Information

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors. A Phase II Study to Identify Molecular Predictors for Hormone Responsiveness and/or Resistance.


This study will develop preliminary data regarding the efficacy and safety of exemestane in
the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is
also designed to develop a predictive model to correlate expression of the known isoforms of
ER and progesterone receptor (PR) and the aromatase enzyme with response to estrogenic
deprivation using exemestane.


Inclusion Criteria:



- Histologically or cytologically confirmed breast cancer

- ER positive (+)

- Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic
disease, provided local-regional surgery is clinically indicated

- Clinical stage II/III

- Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women
with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than
1 year

- Newly diagnosed

- Patients with prior non-breast malignancies are eligible if they have been disease
free for >= 5 years before study entry; patients with squamous or basal cell
carcinoma of the skin that has been effectively treated, carcinoma in situ of the
cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of
the ipsilateral or contralateral breast that has been treated by surgery only are
eligible, even if the cancer was diagnosed within 5 years before randomization

- Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)

- Hemoglobin within normal limits for institution

- Absolute granulocyte count >= 1500

- Platelet count >= 100,000

- Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or
serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x
ULN

- Total bilirubin < 2 x ULN for institution

- Alkaline phosphatase < 2 x the ULN

Exclusion Criteria:

- Completely resected

- Prior hormone or chemotherapy

- Unable to take oral medication

- Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic,
etc.) that would preclude their being subjected to protocol therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Estrogenic deprivation

Outcome Description:

Descriptive analyses will be performed to characterize the variability in the estrogen deprivation levels.

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Principal Investigator

Anthony Elias, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

01-0627.cc

NCT ID:

NCT01831076

Start Date:

April 2002

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • Postmenopausal
  • Exemestane
  • Tamoxifen
  • Breast Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262