Clinical trial · Interventional
Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients
The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
- 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)
1. Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study 2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor. 3. Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anastrozole
- description
- All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery
- interventionNames
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.
- timeFrame
- up to 18 months
- description
- Participants are on study from the time their eligibility is confirmed until the time of their surgery which could be up to 8 weeks. This is a feasibility study and therefore once the study is closed to accrual the percent of women who signed consent and remained on study until their surgery versus those who withdraw will be determined.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed postmenopausal women (Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL and estradiol \< 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.) 2. Confirmation of estrogen receptor positive invasive carcinoma on core biopsy 3. Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon 4. Surgery is planned for the next 2-8 weeks. Exclusion Criteria: 1. History of hormone replacement therapy in the last 6 months 2. Previous treatment by tamoxifen or aromatase inhibitor treatment in six months 3. Known hypersensitivity or contraindications to aromatase inhibitors 4. Known metastatic disease on presentation 5. Recurrent breast cancer 6. Inability to give informed consent
References
Publications (0)
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