Clinical trial · Interventional
Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer
A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy
NCT00084396CI-TRIAL-00024034completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole/Surgery
- interventionNames
- Drug: letrozole
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Predictive model for response as assessed by gene expression profiling
Secondary outcomes (6)
- measure
- Response rate
- measure
- Changes in Ki67 proliferation rates
- measure
- Rate of improvement in surgical outcomes
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating adenocarcinoma of the breast by core needle biopsy * Clinical stage T2-T4a-c, N0-2, M0 * Palpable and measurable disease * Previously untreated disease * Benefits from neoadjuvant therapy that would improve surgical outcome AND meets criteria for 1 of the following: * Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome) AND patient desires breast-conserving surgery * Ineligible for lumpectomy due to size of primary tumor, but modified radical mastectomy feasible AND patient desires breast-conserving surgery * Inoperable disease AND systemic therapy required for disease to become operable by modified radical mastectomy * Bilateral primary tumors allowed provided both tumors are consistent with entry criteria * No inflammatory carcinoma (defined as peau d' orange affecting at least one third of the breast) * Direct extension of the tumor to the skin allowed * No metastatic breast disease, except isolated ipsilateral supraclavicular lymphadenopathy * Hormone receptor status: * Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor PATIENT CHARACTERISTICS: Age * Postmenopausal Sex * Female Menopausal status * Postmenopausal, defined as meeting 1 of the following criteria: * Cessation of menstrual periods for at least 1 year * Bilateral surgical oophorectomy * Follicle-stimulating hormone and estradiol levels in the postmenopausal range Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No severe liver dysfunction that would preclude study participation Renal * Not specified Other * Willing and able to provide biopsy material * Willing to undergo breast surgery after neoadjuvant treatment * No condition (e.g., confusion, infirmity, or alcoholism) that would preclude study compliance * No other concurrent active and progressive invasive malignancies * No other concurrent severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy or biological response modifiers for breast cancer Chemotherapy * No prior chemotherapy for breast cancer * No concurrent chemotherapy for breast cancer Endocrine therapy * At least 2 weeks since prior hormone replacement therapy or phytoestrogenic herbal, alternative, or over-the-counter (OTC) sex hormone remedies * No prior hormonal agents for breast cancer * No prior aromatase inhibitors, tamoxifen, raloxifene, or other antiestrogen or selective estrogen receptor modulators * No concurrent drugs known to affect sex hormone status, including hormone replacement therapy or phytoestrogenic herbal, alternative, or OTC remedies * No other concurrent endocrine therapy for breast cancer Radiotherapy * No prior radiotherapy for breast cancer * No concurrent radiotherapy for breast cancer Surgery * Prior sentinel node biopsy allowed * No other concurrent surgery for breast cancer Other * More than 30 days since prior non-approved or experimental drugs * Concurrent bisphosphonates for osteoporosis allowed * No other concurrent treatment for breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.