Non inferiority study of 'OFS+AI' and 'adjuvant chemotherapy plus endocrine therapy' among premenopausal breast cancer patients in intermediate risk

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018886

Enrollment

Unknown

Registered

2018-10-15

Start date

2018-11-01

Completion date

Unknown

Last updated

2018-10-22

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

Conditions

breast cancer

Interventions

Group 1:OFS+AI

Group 2:adjuvant chemotheapy and endocrine therapy

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. female, premenopausal, aged under 45 years; 2. pathological confirmed invasive breast cancer, TNM stage:T1-2N0-micM0; 3. IHC confirmed ER>50% + and FISH confirmed HER2; 4. undergoing mastectomy or breast conserving surgery, SLNB or ALND; 5. 21 gene recurrence score 11-25; 6. normal blood routine, liver and renal function; 7. ECOG 1-2; 8. not pregnant during treatment and hCG - before treatment; 9. well cooperated and informed consented.

Exclusion criteria

Exclusion criteria: 1) distant metastasis at diagnosis; 2) Dexamethasone allergy or other serious allergy; 3) serious cardiovascular, pulmonary, liver, renal, nervous, or psychiatry disease; 4) pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
disease free survival;	—

Secondary

Measure	Time frame
overall survival;quality of life;	—

Countries

China

Contacts

Public ContactChen Hongliang

Obstetrics and Gynecology Hospital of Fudan University

13671852284@163.com+86 13671852284

Outcome results

None listed

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