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Adjuvant Hormone Therapy
Adjuvant Hormone Therapy is a Hormone therapy Biologic drug developed by Istituto Oncologico Veneto IRCCS. It is currently in Phase 2 development for Breast cancer, hormone receptor-positive.
Adjuvant Hormone Therapy involves the use of hormone-blocking medications to prevent the growth and spread of cancer cells.
Adjuvant Hormone Therapy involves the use of hormone-blocking medications to prevent the growth and spread of cancer cells. Used for Breast cancer, hormone receptor-positive.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 Hormone Therapy |
|---|---|
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Drug class | Hormone therapy |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
This type of therapy typically involves the use of medications such as aromatase inhibitors or selective estrogen receptor modulators to block the production or action of hormones that fuel cancer growth. By reducing hormone levels, these medications can help slow or stop the growth of hormone-sensitive cancers.
Approved indications
- Breast cancer, hormone receptor-positive
Common side effects
- Hot flashes
- Vaginal dryness
- Joint pain
- Fatigue
Key clinical trials
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (PHASE3)
- A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (PHASE3)
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (PHASE3)
- Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment (PHASE3)
- Circulating Tumor DNA (PHASE2)
- Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer (PHASE4)
- Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests (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 Hormone Therapy CI brief — competitive landscape report
- Adjuvant Hormone Therapy updates RSS · CI watch RSS
- Istituto Oncologico Veneto IRCCS portfolio CI
Frequently asked questions about Adjuvant Hormone Therapy
What is Adjuvant Hormone Therapy?
How does Adjuvant Hormone Therapy work?
What is Adjuvant Hormone Therapy used for?
Who makes Adjuvant Hormone Therapy?
What drug class is Adjuvant Hormone Therapy in?
What development phase is Adjuvant Hormone Therapy in?
What are the side effects of Adjuvant Hormone Therapy?
Related
- Drug class: All Hormone therapy drugs
- Manufacturer: Istituto Oncologico Veneto IRCCS — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Breast cancer, hormone receptor-positive
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing