Clinical trial · Interventional
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer
Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
NCT02769104CI-TRIAL-00031067ACCNunknownPhase 3ClinicalTrials.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 investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive 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 |
|---|---|---|---|
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC*4-T*4 | Drug | — | UNRESOLVED |
| Letrozole (Aromatase Inhibitors) | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI+Chemo
- description
- aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC\*4-T\*4) in patients with postmenopausal hormone receptor-positive breast cancer
- interventionNames
- Drug: Letrozole (Aromatase Inhibitors)
- Drug: AC*4-T*4
- type
- ACTIVE_COMPARATOR
- label
- Chemo
- description
- chemotherapy (AC\*4-T\*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer
- interventionNames
- Drug: AC*4-T*4
Primary outcomes (1)
- measure
- effective rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * provision of informed consent * clinical stage IIA\~IIIC * histologically proven HR+ invasive breast cancer * women defined as postmenopausal according to NCCN guideline * plan to accept the neoadjuvant (pre operational) chemotherapy treatment Exclusion Criteria: * clinical evidence of metastatic disease * bilateral oophorectomy; * radiation of the ovaries * patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements * patients who accepted anti-cancer treatment before * previous hormonal therapy as adjuvant treatment for non-cancer disease * patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop * previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied * treatment with a non-approved or experimental drug during 1 month before entry into the study * history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) * leukopenia and/or thrombocytopenia * history of ocular fundus diseases * history of thromboembolic diseases * history of osteoporotic fractures
References
Publications (0)
Data not yet available
No reference posted for this study.