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Placebo + fulvestrant
Placebo + fulvestrant is a Selective Estrogen Receptor Degrader (SERD) Small molecule drug developed by Nanjing Chia-tai Tianqing Pharmaceutical. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, while placebo serves as a control arm in this combination study.
Fulvestrant is being studied in combination with palbociclib and inavolisib (or placebo) for the treatment of breast cancer, metastatic breast cancer, breast tumors, and metastatic cancer. The exact mechanism of fulvestrant is unknown, but it is being used in combination with other treatments in clinical trials.
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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 | Placebo + fulvestrant |
|---|---|
| Sponsor | Nanjing Chia-tai Tianqing Pharmaceutical |
| Drug class | Selective Estrogen Receptor Degrader (SERD) |
| Target | Estrogen Receptor (ER) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fulvestrant works by binding to estrogen receptors (ER) with high affinity and promoting their degradation, thereby blocking estrogen signaling in hormone receptor-positive breast cancer cells. The placebo arm allows for comparison of fulvestrant's efficacy in this Phase 3 trial. This combination approach is designed to evaluate fulvestrant's therapeutic benefit in ER-positive breast cancer.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Hot flashes
- Vaginal bleeding or discharge
- Injection site reactions
- Asthenia/fatigue
- Nausea
Key clinical trials
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
- A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (PHASE2, PHASE3)
- A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (PHASE3)
- A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (PHASE3)
- Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (PHASE3)
- A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer (PHASE3)
- A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (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:
- Placebo + fulvestrant CI brief — competitive landscape report
- Placebo + fulvestrant updates RSS · CI watch RSS
- Nanjing Chia-tai Tianqing Pharmaceutical portfolio CI
Frequently asked questions about Placebo + fulvestrant
What is Placebo + fulvestrant?
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Related
- Drug class: All Selective Estrogen Receptor Degrader (SERD) drugs
- Target: All drugs targeting Estrogen Receptor (ER)
- Manufacturer: Nanjing Chia-tai Tianqing Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing