OncoMatch/Clinical Trials/NCT05879926
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Is NCT05879926 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ovarian Function Suppression + Aromatase Inhibitor and Adjuvant Chemotherapy + Ovarian Function Suppression for breast cancer.
Treatment: Ovarian Function Suppression + Aromatase Inhibitor · Adjuvant Chemotherapy + Ovarian Function Suppression — This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>=1% ER staining by IHC)
The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.
Required: PR (PGR) overexpression (>=1% PgR staining by IHC)
The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.
Required: HER2 (ERBB2) wild-type (HER2-negative by ASCO/CAP guidelines)
The tumor must be HER2-negative by current ASCO/CAP guidelines based on local testing results.
Disease stage
Required: Stage PT1, PT2, PT3 (AJCC 8th edition)
Excluded: Stage PT4
By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.) By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). pT4 (pathological state) tumors, including inflammatory breast cancer [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy — neoadjuvant or adjuvant
Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy.
Cannot have received: radiation therapy
Exception: allowed if for prior ipsilateral DCIS treated with lumpectomy and XRT, but current cancer must have been treated with mastectomy
Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.)
Cannot have received: chemotherapy
Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry.
Cannot have received: biotherapy
Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry.
Cannot have received: endocrine therapy
Exception: allowed if less than 6 weeks duration for current cancer; prior tamoxifen for prevention allowed; prior AI or GnRH for fertility preservation allowed
Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.
Lab requirements
Blood counts
ANC ≥ 1200/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 10 g/dL
Kidney function
GFR ≥ 30 mL/min/1.73m2
Liver function
Total bilirubin ≤ ULN (or ≤ 1.5 x ULN for Gilbert's disease); AST/ALT ≤ 3 x ULN
Cardiac function
NYHA class 2B or better if cardiac disease or prior cardiotoxic therapy
ANC less than 1200/mm3; Platelet count less than 100,000/mm3; Hemoglobin less than 10 g/dL; Total bilirubin greater than ULN (or >1.5 x ULN for Gilbert's disease); AST/ALT >3 x ULN; GFR <30 mL/min/1.73m2. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
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