Phase 3
Completed N=622
Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
Source: ClinicalTrials.gov NCT00265759 ↗Enrolled (actual)
622
Serious AEs
6.5%
Results posted
Mar 2017
Primary outcomePrimary: Clinical Response (Complete or Partial Response) Rate (Cohort A) — 62.9; 74.8; 69.1 percentage of patients
◆ Published Evidence
Highly cited
560citations · ~37 / year
Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype--ACOSOG Z1031.
Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.
Linked Publications (3)
-
Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype--ACOSOG Z1031.
-
Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance).
-
Mismatch repair deficiency predicts response to HER2 blockade in HER2-negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response (Complete or Partial Response) Rate (Cohort A) |
62.9; 74.8; 69.1 | — |
| PRIMARY Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B) |
5.7 | — |
| SECONDARY Toxicity (Cohort A) |
2; 2; 3; 2; 4; 2 | — |
| SECONDARY Disease-free Survival (DFS) (Cohort A and B) |
84.5; 87.4 | — |
| SECONDARY Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A) |
85.2; 77.4; 86.4 | — |
| SECONDARY Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A) |
— | — |
| SECONDARY Rate of Lymph Node Involvement (LNI) (Cohort A) |
41.1; 48.2; 44.1 | — |
| SECONDARY The Pathologic Complete Response (pCR) Rate (Cohort A) |
1.7; 0.0; 0.0 | — |
| SECONDARY Clinical Response Rate (Cohort B) |
— | — |
| SECONDARY Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A) |
48.1; 42.1; 60.0 | — |
| SECONDARY Percentage of Participants With Overall Survival (Cohort A and B) |
88.1; 88.6 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- T2-T4c, any N, M0 disease
- Clinically staged, as documented by the treating physician, as 1 of the following:
- T4a-c disease for which modified radical mastectomy with negative margins is the goal
- T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal
- T2 disease for which lumpectomy at first attempt is the goal
- Primary tumor must be palpable and measure > 2 cm by tape, ruler, or caliper measurements in at least one dimension
- Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy
- No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
- No distant metastasis (M1)
- Isolated ipsilateral supraclavicular node involvement allowed
- No diagnosis that was established by incisional biopsy
- Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8
- Patients with > 66.66% (two-thirds) of cells staining positive and have a minimum Allred score of 6 are eligible
PATIENT CHARACTERISTICS:
- ECOG/Zubrod performance status of ≤ 2
- Female
- Patient must be postmenopausal, verified by 1 of the following:
- Bilateral surgical oophorectomy
- No spontaneous menses ≥ 1 year
- No menses for < 1 year with FSH and estradiol levels in postmenopausal range
- No other malignancies within the past 5 years, except for successfully treated cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral ductal carcinoma in situ that was treated with mastectomy or lumpectomy with radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of recurrence
- Must have undergone potentially curative therapy for all prior malignancies AND deemed to be at low risk for recurrence, according to the treating physician
PRIOR CONCURRENT THERAPY:
- No prior treatment for invasive breast cancer, including radiotherapy, endocrine therapy, chemotherapy, or investigational agents
- No prior sentinel lymph node biopsy (cohort B only)
- At least 1 week since prior agents with estrogenic or putatively estrogenic properties, including herbal preparations
- At least 1 week since prior hormone replacement therapy of any type, megestrol acetate, or raloxifene
- No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer
- No other concurrent anti-neoplastic therapy, including chemotherapy or radiotherapy
- No concurrent agents or herbal products that alter ER function
Data sourced from ClinicalTrials.gov (NCT00265759) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.