Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Conditions
Keywords
Breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, Postmenopausal, Exemestane, Tamoxifen
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.
Interventions
DRUGExemestane
Given PO
DRUGExemestane and tamoxifen
exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Exemestane: Given PO | 31 |
| Exemestane Plus Tamoxifen preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with \>T2 ER+ Her2- BC. | 5 |
| Total | 36 |
Baseline characteristics
| Characteristic | Exemestane Plus Tamoxifen | Exemestane | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 13 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 18 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 19 Participants | 24 Participants |
| Region of Enrollment United States | 5 participants | 31 participants | 36 participants |
| Sex: Female, Male Female | 5 Participants | 31 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 5 |
| serious Total, serious adverse events | 0 / 31 | 0 / 5 |
Outcome results
Primary
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.
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exemestane | Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings | 23 Participants |
| Exemestane Plus Tamoxifen | Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings | 0 Participants |