A non-randomized study of preoperative chemotherapy with or without endocrine therapy in hormone receptor positive breast cancer

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16007962

Enrollment

Unknown

Registered

2016-02-22

Start date

2016-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Combined Chemoendocrine Therapy:chemotherapy (Epirubicin plus paclitaxel) combined with aromatase inhibitor ± goserelin (according to menopausal status)

Chemotherapy:chemotherapy (Epirubicin plus paclitaxel)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. ER positive >=50%; 2. HER2 negative (defined as IHC graded 0 to 1+ or 2+ with FISH confirmed negative); 3. Histopathologically confirmed invasive breast cancer with histopathologically or cytologically confirmed axillary lymph node metastasis (preoperative SLNB is not allowed since it may interfere the pCR evaluation of axillary lymph node); 4. Indication for neoajuvant chemotherapy; 5. Indications for adjuvant chemotherapy after surgery; 6. No clinical evidence of other malignancy, unstable complication or uncontrolled infection; 7. No evidence of contraindication of chemotherapy or endocrine therapy; 8. Voluntary participation and written informed consent provided.

Exclusion criteria

Exclusion criteria: 1. Pathologically or radiologically defined distant metastasis; 2. History of other malignancy; 3. Contraindications of LHRHa or chemotherapy 4. Contraindications of neoadjuvant chemotherapy: severe cardio-cerebralvascular disease, liver or renal dysfunction, hematological disease, or any other inadaptable conditions defined by researcher; 5. Contrindications of surgery: anesthesia intolerance, extensive disease which is unresectable 6. Inadaptable systemic conditions 7. Unsuitable for the procedure, evaluated by researcher 8. Previous or prensent other anti-tumor treatment or plan to participate other clinical trial 9. Patient's refusal

Design outcomes

Primary

Measure	Time frame
Residual Invasive Tumor Size, RITS;	—

Secondary

Measure	Time frame
Pathological response (Miller-Payne grading system);Axillary lymph node positive rate;	—

Countries

China

Contacts

Public ContactXiang wang

xiangw@vip.sina.com+86 13801189130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026