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NCT04216472
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
Phase 2 trial testing Alpelisib in Anatomic Stage I Breast Cancer AJCC v8 in 6 participants. Terminated before completion.
22 September 2025
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 5 February 2020 |
| Primary completion | 22 September 2025 |
| Estimated completion | 22 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alpelisib (alpelisib) — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Conditions studied
- Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
- Anatomic Stage IA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IA Breast Cancer AJCC v8 →
- Anatomic Stage IB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IB Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage IA Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well nab-paclitaxel and alpelisib works in treating patients with triple negative breast cancer with PIK3CA or PTEN alterations that does not respond to anthracycline chemotherapy (anthrocycline refractory). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nab-paclitaxel and alpelisib before surgery may help shrink the tumor before surgery.
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 -
Practical classification of triple-negative breast cancer: intratumoral heterogeneity, mechanisms of drug resistance, and novel therapies.
Marra A, Trapani D, Viale G, Criscitiello C, et al · · 2020 · cited 209× · PMID 33088912 · DOI 10.1038/s41523-020-00197-2 -
Recent advances in targeted strategies for triple-negative breast cancer.
Zhu S, Wu Y, Song B, Yi M, et al · · 2023 · cited 200× · PMID 37641116 · DOI 10.1186/s13045-023-01497-3 -
Triple-negative breast cancer: promising prognostic biomarkers currently in development.
Sukumar J, Gast K, Quiroga D, Lustberg M, et al · · 2021 · cited 158× · PMID 33198517 · DOI 10.1080/14737140.2021.1840984 -
Molecular Mechanisms, Biomarkers and Emerging Therapies for Chemotherapy Resistant TNBC.
Ferrari P, Scatena C, Ghilli M, Bargagna I, et al · · 2022 · cited 143× · PMID 35163586 · DOI 10.3390/ijms23031665 -
Triple-negative breast cancer: A run-through of features, classification and current therapies.
Manjunath M, Choudhary B. · · 2021 · cited 76× · PMID 33986872 · DOI 10.3892/ol.2021.12773 -
Clinical and Biomarker Results from Phase I/II Study of PI3K Inhibitor Alpelisib plus Nab-paclitaxel in HER2-Negative Metastatic Breast Cancer.
Sharma P, Abramson VG, O'Dea A, Nye L, et al · · 2021 · cited 67× · PMID 33602685 · DOI 10.1158/1078-0432.ccr-20-4879 -
Role of Alpelisib in the Treatment of PIK3CA-Mutated Breast Cancer: Patient Selection and Clinical Perspectives.
Chang DY, Ma WL, Lu YS. · · 2021 · cited 62× · PMID 33707948 · DOI 10.2147/tcrm.s251668
Verify or expand the search:
- PubMed search for NCT04216472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT04967248 — A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced o · terminated
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Other M.D. Anderson Cancer Center trials
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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 NCT04216472 (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 M.D. Anderson Cancer Center
- Last refreshed: 30 September 2025
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/NCT04216472.
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