Evidence map›Paper›PMID 39159418›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With

Asma Dilawari, James Buturla, Christy Osgood, Xin Gao, Wei Chen, Tiffany K Ricks, Timothy Schaefer, Sreedevi Avasarala, Francisca Reyes Turcu, Anand Pathak and 9 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Asma DilawariCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-5706-9138
James ButurlaCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Christy OsgoodCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Xin GaoCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7383-6453
Wei ChenCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Tiffany K RicksCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Timothy SchaeferCenter for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD.
Sreedevi AvasaralaCenter for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD.
Francisca Reyes TurcuCenter for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD.
Anand PathakCenter for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD.
Shyam KalavarCenter for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD.
Vishal BhatnagarOncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, MD.
Justin CollazoCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0009-0002-7252-8974
Nam Atiqur RahmanCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
Bronwyn MixterOncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-5277-4399
Shenghui TangCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0437-665X
Richard PazdurOncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4771-9923
Paul KluetzOncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, MD.
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0056-5437

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

purposeThe US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, or metastatic breast cancer (MBC) who have received at least one previous endocrine therapy and whose tumors harbor one or more phosphatidylinositol 3-kinase ( PATIENTS AND

methodsApproval was based on CAPItello-291, a randomized, double-blind, multicenter trial of 708 patients with hormone receptor-positive, HER2-negative advanced or MBC, including 289 patients with

resultsA statistically significant progression-free survival (PFS) benefit was demonstrated in the overall population (hazard ratio [HR], 0.6 [95% CI, 0.51 to 0.71]); this result was driven by 289 patients in the biomarker-positive population (HR, 0.5 [95% CI, 0.37 to 0.68]). An exploratory analysis of investigator-assessed PFS in the 313 (44%) patients in the biomarker-negative population showed uncertain benefit (HR, 0.78 [95% CI, 0.60 to 1.01]). With capivasertib, more patients had Grade ≥3 toxicities. Key concerns included hyperglycemia (18% all-grade, 2.8% Grade ≥3), cutaneous toxicity (58% all-grade, 17% Grade ≥3), and diarrhea (72% all-grade, 9% Grade ≥3).

conclusionCapivasertib with fulvestrant was approved for patients whose tumors harbored

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDrug ApprovalErb-b2 Receptor Tyrosine KinasesFulvestrantPyrimidinesReceptors, EstrogenAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMiddle AgedProgression-Free SurvivalAKT1 protein, humancapivasertibClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantPIK3CA protein, humanProto-Oncogene Proteins c-aktPTEN PhosphohydrolasePTEN protein, humanPyrimidinesPyrrolesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID39159418
PMCPMC11588547

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.