Capivasertib+Paclitaxel as First Line… · NCT03997123

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC is a phase 3 interventional study registered as NCT03997123 by AstraZeneca, with 923 participants enrolled, started 2019-06-25 and due to reach its primary completion in 2026-03-16. Interventions recorded: Capivasertib, Paclitaxel and Placebo.

Setting

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

Phase

Phase 3

Sponsor

AstraZeneca

Registry

NCT03997123

Headline result

Overall survival 17.7 vs 18.0 months (HR 0.92, p 0.32) overall and 20.4 vs 20.4 months (HR 1.05) in PIK3CA/AKT1/PTEN-altered tumours; PFS 5.6 vs 5.1 months (HR 0.72).

Started

2019-06-25

Reported

2026

Enrolled

923 randomisedClinicalTrials.gov lists 923 participants (actual); the Annals of Oncology 2026 primary paper covers 812 randomised patients.

Outcomes

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In plain words

What these results mean for people, not percentages

923 randomised

Overall survival, all patientsprimarysurvival endpoint

Median 17.7 vs 18 months with Capivasertib + paclitaxel compared with Placebo + paclitaxel; about 0.3 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 8 percent lower chance of the event at any given time (hazard ratio 0.92, likely range 0.78 to 1.08).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Overall survival, PIK3CA/AKT1/PTEN-altered tumoursprimarysurvival endpoint

Median 20.4 vs 20.4 months with Capivasertib + paclitaxel compared with Placebo + paclitaxel; about 0 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.77 to 1.43).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Progression-free survival (investigator), all patientssurrogate endpoint

Median 5.6 vs 5.1 months with Capivasertib + paclitaxel compared with Placebo + paclitaxel; about 0.5 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.61 to 0.84).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

923 randomised.

Overall survival, all patientsprimary

HR 0.92 (0.78 to 1.08) · p = 0.3239

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Source

Overall survival, PIK3CA/AKT1/PTEN-altered tumoursprimary

HR 1.05 (0.77 to 1.43) · p = 0.7602

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Source

Progression-free survival (investigator), all patients

HR 0.72 (0.61 to 0.84)

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall survival, all patientsprimary	Capivasertib + paclitaxel	-	17.7 months	0.92 (0.78 to 1.08)	0.3239	link
Overall survival, all patientsprimary	Placebo + paclitaxel	-	18 months	0.92 (0.78 to 1.08)	0.3239	link
Overall survival, PIK3CA/AKT1/PTEN-altered tumoursprimary	Capivasertib + paclitaxel	-	20.4 months	1.05 (0.77 to 1.43)	0.7602	link
Overall survival, PIK3CA/AKT1/PTEN-altered tumoursprimary	Placebo + paclitaxel	-	20.4 months	1.05 (0.77 to 1.43)	0.7602	link
Progression-free survival (investigator), all patients	Capivasertib + paclitaxel	-	5.6 months	0.72 (0.61 to 0.84)	-	link
Progression-free survival (investigator), all patients	Placebo + paclitaxel	-	5.1 months	0.72 (0.61 to 0.84)	-	link

Notes

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Primary paper (Annals of Oncology 2026): 812 untreated metastatic patients randomised July 2019 to February 2022 to paclitaxel 80 mg/m2 with capivasertib 400 mg or placebo twice daily on days 2 to 5 of weeks 1 to 3; 30.7 percent had PIK3CA, AKT1 or PTEN alterations. Neither overall survival endpoint met its boundary; grade 3 or higher diarrhoea 12.7 versus 0.7 percent; adverse events led to death in 4.2 percent. UK sites (registry, 7): Edinburgh, London (3), Sheffield, Surrey, York. NICE appraisal GID-TA11411 discontinued.

Key papers

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rctAnnals of Oncology 20269 citations

Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: results from the randomised, global phase III CAPItello-290 trial

The latest in a line of negative targeted-therapy trials in triple-negative disease (EGFR, VEGF, iniparib, now AKT): a modest delay in progression that did not translate into survival, in the same year that an antibody-drug conjugate did. It is why the roadmap treats pathway-targeted small molecules as the road not taken.

Connected

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Trial
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors and the tag pipeline.
Trial
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors and the tag pipeline.
Treatment
Ipatasertib
Shares LOTUS, IPATunity130, BARBICAN, Metastatic triple-negative breast cancer and the tag pipeline.
Trial
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
Shares PI3K, AKT and mTOR inhibitors, Capivasertib, AstraZeneca, Small-molecule kinase inhibitors and the tag pipeline.
Trial
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Shares Capivasertib, Metastatic triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites), AstraZeneca and the tag pipeline.
Trial
A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
Shares Metastatic triple-negative breast cancer, AstraZeneca, Triple-negative breast cancer (TNBC) and the tag pipeline.
Trial
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors and the tag pipeline.
Trial
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
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors and the tag pipeline.

drugs

ApprovedSmall-molecule AKT inhibitor

Capivasertib · Truqap

ApprovedCytotoxic chemotherapy (taxane)

Paclitaxel / nab-paclitaxel · Taxol / Abraxane

companies

AstraZeneca

terms

Triple-negative breast cancer trials open today (registry snapshot and UK sites)

trials

BARBICAN IPATunity130 LOTUS PAKT

roadmaps

Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem

key papers

Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: results from the randomised, global phase III CAPItello-290 trial

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

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