Clinical trial · Interventional
Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).
NCT00738777CI-TRIAL-00049569suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): in preparation for an amendment
Summary
Brief summary (as posted)
To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Anastrozole+Fulvestrant | Drug | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Anastrozole
- interventionNames
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- 2
- description
- Anastrozole + Fulvestrant
- interventionNames
- Drug: Anastrozole+Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Tamoxifen
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with proven invasive adenocarcinoma of the breast * Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer) * WHO-performance score 0 or 1 * Written informed consent Exclusion Criteria: * Clues of metastatic disease by clinical examination according to most recent NABON guidelines * Multicentric breast cancer * Inflammatory breast cancer * Hormone replacement during the last 12 months * Other systemic treatment during the waiting time till surgery * Already planned date for surgery within the next 2 weeks * Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol * Patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment NB: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS within the last 15 years is not an exclusion criterium. NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.
References
Publications (1)
- DERIVEDReinema FV, Sweep FCGJ, Adema GJ, Peeters WJM, Martens JWM, Bussink J, Span PN. Tamoxifen induces radioresistance through NRF2-mediated metabolic reprogramming in breast cancer. Cancer Metab. 2023 Feb 8;11(1):3. doi: 10.1186/s40170-023-00304-4. PMID 36755288