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NCT Number: NCT01831076

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage II Breast Cancer Stage III Breast Cancer

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exemestane

Drug

Given PO

Other names: 107868-30-4,, 6-Methyleneandrosta-1,, 4-diene-3,17-dione,, 713563,, Aromasin,, FCE 24304,, FCE-24304,, PNU 155971

Exemestane and tamoxifen

Drug

exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Primary outcomes

  1. Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2013
Study completion
2022
First posted
Apr 15, 2013
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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