Clinical trial · Interventional
Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane
NCT00291798CI-TRIAL-00000450completedPhase 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)
The objective of the present clinical investigation is to determine whether hormonal therapy given preoperatively is able to reduce tumor size to an extent that facilitates breast-conserving procedures.
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 |
|---|---|---|---|
| rate of remission | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- rate of remission
Secondary outcomes (4)
- measure
- Toxicity (WHO-grading)
- measure
- rate of mastectomy
- measure
- response of tumor subject to HER2-status
- measure
- collection of disease free survival and overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified breast cancer (punch biopsy), established HER-2/neu status * Postmenopausal patients (\> 1 year following outset of menopause and/or postmenopausal hormonal profile) * Clinical staging: T2 (\> 3 cm), T3, T4a-c, N0-1 * Hormone receptor positivity, i.e. estrogen and/or progesterone receptor \> 10 fmol/mg cytosolic protein or ER-ICA-positive and/or PgR-ICA-positive. Positivity of + (low-grade) in one hormone receptor is only eligible in the presence of positivity in the other hormone receptor. * no internal contraindication * life expectation \> 6 month * written informed consent Exclusion Criteria: * premenopausal patients and patients with no clearly indicated menopausal status * manifest second malignant tumor (except basalioma or in situ carcinoma of cervix uteri) * uncontrolled internal disease i.e. diabetes mellitus, cardiac disease (NYHA III/IV) * thromboembolic disease * inflammatory mamma carcinoma * existence of distant metastases * former or simultaneously therapy with antioestrogens, aromatase inhibitors, cytostatics or radiotherapy * corticosteroids before and during the study (except inhalant application) * lack of compliance
References
Publications (0)
Data not yet available
No reference posted for this study.