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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01831076
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 237.2
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer	Drug: Exemestane; Drug: Exemestane and tamoxifen	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Jan 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment (exemestane, surgery) Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.	Drug: Exemestane; Given PO; Other Names: 107868-30-4, 6-Methyleneandrosta-1, 4-diene-3,17-dione, 713563, Aromasin, FCE 24304, FCE-24304, PNU 155971
Experimental: treatment (exemestane, tamoxifen, surgery) Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.	Drug: Exemestane and tamoxifen; exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings [Up to 6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Anthony Elias, M.D, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01831076
• Other Study ID Numbers: 01-0627.cc
• First Posted: Apr 15, 2013
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Colorado, Denver: Breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; Postmenopausal; Exemestane; Tamoxifen
• Additional relevant MeSH terms: Breast Neoplasms; Tamoxifen; Exemestane

Study Results

Participant Flow

Arm/Group Title	Exemestane	Exemestane Plus Tamoxifen
Arm/Group Description	Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
Period Title: Overall Study
STARTED	31	5
COMPLETED	30	4
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Exemestane	Exemestane Plus Tamoxifen	Total
Arm/Group Description	Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.	Total of all reporting groups
Overall Participants	31	5	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 58.1%	4 80%	22 61.1%
>=65 years	13 41.9%	1 20%	14 38.9%
Sex: Female, Male (Count of Participants)
Female	31 100%	5 100%	36 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 6.5%	0 0%	2 5.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 9.7%	0 0%	3 8.3%
White	19 61.3%	5 100%	24 66.7%
More than one race	7 22.6%	0 0%	7 19.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%	5 100%	36 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exemestane	Exemestane Plus Tamoxifen
Arm/Group Description	Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
Measure Participants	31	5
Count of Participants [Participants]	23 74.2%	0 0%

Adverse Events

Time Frame	Consent to surgery (approximately four months)
Adverse Event Reporting Description	Adverse event collection and reporting not required by protocol. Only SAE reporting required.
Arm/Group Title	Exemestane		Exemestane Plus Tamoxifen
Arm/Group Description	Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO		preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
All Cause Mortality
	Exemestane		Exemestane Plus Tamoxifen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exemestane		Exemestane Plus Tamoxifen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Exemestane		Exemestane Plus Tamoxifen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.