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NCT04335006
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.
Phase 3 trial testing Carelizumab in Breast Cancer in 80 participants. Terminated before completion.
14 April 2023
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 14 July 2020 |
| Primary completion | 14 April 2023 |
| Estimated completion | 14 April 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Carelizumab — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
- Apatinib (Apatinib) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, female only, with Breast Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances in therapeutic strategies for triple-negative breast cancer.
Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0 -
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
Immunotherapy for Triple-Negative Breast Cancer: Combination Strategies to Improve Outcome.
Li L, Zhang F, Liu Z, Fan Z. · · 2023 · cited 73× · PMID 36612317 · DOI 10.3390/cancers15010321 -
Immunotherapy for Triple-Negative Breast Cancer.
Cao Y, Chen C, Tao Y, Lin W, et al · · 2021 · cited 17× · PMID 34959285 · DOI 10.3390/pharmaceutics13122003 -
Evolving treatment landscape of immunotherapy in breast cancer: current issues and future perspectives.
Valenza C, Rizzo G, Passalacqua MI, Boldrini L, et al · · 2023 · cited 10× · PMID 36743524 · DOI 10.1177/17588359221146129 -
Drug Repurposing to Circumvent Immune Checkpoint Inhibitor Resistance in Cancer Immunotherapy.
To KKW, Cho WC. · · 2023 · cited 7× · PMID 37631380 · DOI 10.3390/pharmaceutics15082166 -
Path to Clonal Theranostics in Luminal Breast Cancers.
Hajjaji N, Aboulouard S, Cardon T, Bertin D, et al · · 2021 · cited 7× · PMID 35096604 · DOI 10.3389/fonc.2021.802177 -
Eribulin combined with antiangiogenic agents in women with HER2-negative metastatic breast cancer: a retrospective multicenter study.
Jiang M, Shao B, Wan D, Liu J, et al · · 2023 · cited 5× · PMID 37841751 · DOI 10.1177/17588359231204856
Verify or expand the search:
- PubMed search for NCT04335006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04335006 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 6 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04335006.
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