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OncoMatch/Clinical Trials/NCT02535221

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Is NCT02535221 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Goserelin+TAM+AI and Epirubicin+CTX+5-Fu for breast cancer.

Phase 3RecruitingPeking UniversityNCT02535221Data as of Jun 2026Location: China

Treatment: Goserelin+TAM+AI · Epirubicin+CTX+5-FuThis study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

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Extracted eligibility criteria

Treatments studied

Other

Goserelin+TAM+AIEpirubicin+CTX+5-Fu

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 ER positive (>50% cell in IHC) (>50% cell in IHC)

Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC)

Required: PR (PGR) PR positive (>50% cell in IHC) (>50% cell in IHC)

Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC)

Required: HER2 (ERBB2) negative

HER2 negative breast cancer by pathological evaluation

Disease stage

Required: Stage T2N0M0 (TNM)

Excluded: Stage LYMPH NODE POSITIVE

Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)

Demographics

Ages 35–55
Female only

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-tumor treatment

No other previous treatment for primary breast cancer; have been attendance in other anti-tumor treatment or other clinical trials

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT02535221 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ESR1?

Yes, ESR1 ER positive (>50% cell in IHC) is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR PR positive (>50% cell in IHC) is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 negative is a required biomarker for enrollment.

What disease stage is eligible?

Stage T2N0M0 is required.

Is there an age limit?

Yes. Patients must be 55 years or younger and at least 35 years old.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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