NCT04464174 (PATHFINDER) is a Phase 2 clinical trial of Ipatasertib in Triple Negative Breast Cancer, sponsored by MedSIR.

Who is sponsoring NCT04464174?

NCT04464174 is sponsored by MedSIR.

What drugs are being tested in NCT04464174?

Interventions in NCT04464174: Ipatasertib, Capecitabine, Eribulin, Carboplatin, Gemcitabine.

What condition does NCT04464174 study?

NCT04464174 studies Triple Negative Breast Cancer.

Is NCT04464174 still recruiting?

NCT04464174 is currently completed. Last updated 26 July 2024.

Last reviewed 2024-07-26 · How we verify

NCT04464174: PATHFINDER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer

Completed Phase 2 Last updated 26 July 2024

What this trial tests

Phase 2 trial testing Ipatasertib in Triple Negative Breast Cancer in 54 participants. Completed in 10 November 2023.

Timeline

8 October 2020

Primary endpoint
10 November 2023

10 November 2023

Quick facts

Lead sponsor	MedSIR
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	8 October 2020
Primary completion	10 November 2023
Estimated completion	10 November 2023
Sites	14 locations across Portugal, Spain

Drugs / interventions tested

Ipatasertib (ipatasertib) — full drug profile →
Capecitabine (capecitabine) — full drug profile →
Eribulin (ERIBULIN) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

MedSIR — full company profile →

Who can join

18 and older, female only, with Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, non-comparative, three-arm, phase IIa trial of Ipatasertib (GDC-0068) in combination with non-taxane chemotherapy agents for taxane-pretreated unresectable locally advanced or metastatic triple-negative breast cancer patients

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
Breast Cancer Treatments: Updates and New Challenges.
Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
AKT Inhibitors: New Weapons in the Fight Against Breast Cancer?
Martorana F, Motta G, Pavone G, Motta L, et al · · 2021 · cited 154× · PMID 33995085 · DOI 10.3389/fphar.2021.662232
PI3K/AKT/mTOR signaling pathway: an important driver and therapeutic target in triple-negative breast cancer.
Zhang HP, Jiang RY, Zhu JY, Sun KN, et al · · 2024 · cited 91× · PMID 38630392 · DOI 10.1007/s12282-024-01567-5
Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy.
Sirico M, D'Angelo A, Gianni C, Casadei C, et al · · 2023 · cited 76× · PMID 36765661 · DOI 10.3390/cancers15030703
Immunometabolism in cancer: basic mechanisms and new targeting strategy.
Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
Personalised Therapies for Metastatic Triple-Negative Breast Cancer: When Target Is Not Everything.
Capici S, Ammoni LC, Meli N, Cogliati V, et al · · 2022 · cited 13× · PMID 35954393 · DOI 10.3390/cancers14153729

Verify or expand the search:

Other trials of Ipatasertib

Trials testing the same drug.

NCT05554380 — Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Tria · Phase 2 · suspended
NCT05862285 — A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study · Phase 3 · recruiting
NCT05564377 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The Co · Phase 2 · recruiting
NCT05538897 — Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recur · Phase 1, PHASE2 · active not recruiting
NCT05172245 — Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer · Phase 1 · recruiting

Other recruiting trials for Triple Negative Breast Cancer

Currently open trials in the same condition.

NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer · Phase 1, PHASE2 · recruiting
NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · recruiting

Other MedSIR trials

Trials by the same sponsor.

NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04464174 (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 MedSIR
Last refreshed: 26 July 2024

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/NCT04464174.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing