Last reviewed · How we verify
Adjuvant Chemotherapy + Ovarian Function Suppression
Adjuvant Chemotherapy + Ovarian Function Suppression is a Combination regimen (chemotherapy + endocrine therapy) Small molecule drug developed by NRG Oncology. It is currently in Phase 3 development for Premenopausal women with early-stage breast cancer (adjuvant setting), Hormone receptor-positive breast cancer with ovarian function preservation.
This combination treatment uses chemotherapy drugs to kill cancer cells while simultaneously suppressing ovarian function to reduce estrogen production and protect fertility in premenopausal women with breast cancer.
Adjuvant chemotherapy combined with ovarian function suppression is a treatment approach studied in clinical trials for early breast cancer. The mechanism of action of adjuvant chemotherapy is not specified in available databases, but ovarian function suppression is often used in conjunction with aromatase inhibitors to reduce estrogen levels in the body.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Adjuvant Chemotherapy + Ovarian Function Suppression |
|---|---|
| Sponsor | NRG Oncology |
| Drug class | Combination regimen (chemotherapy + endocrine therapy) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Adjuvant chemotherapy delivers cytotoxic agents systemically to eliminate residual cancer cells after surgery. Ovarian function suppression (typically via GnRH agonists or oophorectomy) reduces circulating estrogen levels, which may improve outcomes in hormone receptor-positive breast cancer and simultaneously preserves ovarian function and fertility in younger patients by inducing temporary or permanent amenorrhea that protects oocytes from chemotherapy damage.
Approved indications
- Premenopausal women with early-stage breast cancer (adjuvant setting)
- Hormone receptor-positive breast cancer with ovarian function preservation
Common side effects
- Nausea and vomiting
- Alopecia
- Myelosuppression
- Amenorrhea
- Hot flashes
- Fatigue
Key clinical trials
- 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 (PHASE3)
- Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (PHASE3)
- Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHASE2)
- CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer (PHASE3)
- Premenopausal Endocrine Responsive Chemotherapy Trial (PHASE3)
- Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea (PHASE3)
- Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Adjuvant Chemotherapy + Ovarian Function Suppression CI brief — competitive landscape report
- Adjuvant Chemotherapy + Ovarian Function Suppression updates RSS · CI watch RSS
- NRG Oncology portfolio CI
Frequently asked questions about Adjuvant Chemotherapy + Ovarian Function Suppression
What is Adjuvant Chemotherapy + Ovarian Function Suppression?
How does Adjuvant Chemotherapy + Ovarian Function Suppression work?
What is Adjuvant Chemotherapy + Ovarian Function Suppression used for?
Who makes Adjuvant Chemotherapy + Ovarian Function Suppression?
What drug class is Adjuvant Chemotherapy + Ovarian Function Suppression in?
What development phase is Adjuvant Chemotherapy + Ovarian Function Suppression in?
What are the side effects of Adjuvant Chemotherapy + Ovarian Function Suppression?
Related
- Drug class: All Combination regimen (chemotherapy + endocrine therapy) drugs
- Manufacturer: NRG Oncology — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Premenopausal women with early-stage breast cancer (adjuvant setting)
- Indication: Drugs for Hormone receptor-positive breast cancer with ovarian function preservation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing