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Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

Primary Purpose

Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exemestane
Exemestane and tamoxifen
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, Postmenopausal, Exemestane, Tamoxifen

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment (exemestane, surgery)

treatment (exemestane, tamoxifen, surgery)

Arm Description

Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Outcomes

Primary Outcome Measures

Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2013
Last Updated
February 22, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01831076
Brief Title
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2002 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Keywords
Breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, Postmenopausal, Exemestane, Tamoxifen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (exemestane, surgery)
Arm Type
Active Comparator
Arm Description
Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Arm Title
treatment (exemestane, tamoxifen, surgery)
Arm Type
Experimental
Arm Description
Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
107868-30-4,, 6-Methyleneandrosta-1,, 4-diene-3,17-dione,, 713563,, Aromasin,, FCE 24304,, FCE-24304,, PNU 155971
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Exemestane and tamoxifen
Intervention Description
exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery
Primary Outcome Measure Information:
Title
Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings
Description
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Elias, M.D
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

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