Summary
What is this summary about?
This is a summary of the article discussing the results of the CAPItello-291 study. In the study, participants had advanced breast cancer that could not be completely removed with surgery, and that was diagnosed as a type of breast cancer where tumor cells had hormone receptors (HR-positive) but did not have HER2 receptors (HER2-negative). All participants were also required to have previously received treatment with a type of therapy called an aromatase inhibitor (with or without a CDK4/6 inhibitor), but over time their cancer cells had still grown or spread. The CAPItello-291 study researchers wanted to find out if a treatment combination of the medications capivasertib plus fulvestrant worked better than placebo plus fulvestrant. Capivasertib is a drug that blocks the activity of a protein called AKT, which is found inside breast cancer cells.
What are the key takeaways?
The main finding was that participants who took capivasertib plus fulvestrant lived longer without their disease getting worse (progressing) compared with those treated with placebo plus fulvestrant. This is called progression-free survival. This result was seen across all participants (median progression-free survival of 7.2 months with capivasertib plus fulvestrant vs 3.6 months with placebo plus fulvestrant). It was also seen in participants whose tumors had detectable genetic alterations in genes called PIK3CA, AKT1, and/ or PTEN (median progression-free survival of 7.3 months with capivasertib plus fulvestrant vs 3.1 months with placebo plus fulvestrant). The most common side effects experienced by participants included diarrhea and different types of rash. These were as expected (given how capivasertib works). The CAPItello-291 study is still ongoing, and more results are expected to be released in the future.
What were the main conclusions reported by the researchers?
Results from the CAPItello-291 study showed that capivasertib plus fulvestrant compared with placebo plus fulvestrant improved progression-free survival in participants with HR-positive/ HER2-negative advanced breast cancer whose cancer had grown or spread despite hormone therapy (with/without a CDK4/6 inhibitor).
Clinical Trial Registration: NCT04305496 (CAPItello-291) (ClinicalTrials.gov)
Keywords: : advanced breast cancer, breast, capivasertib, clinical trials, fulvestrant
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to original article here
Acknowledgments
AstraZeneca would like to thank all the patients and their families, as well as all the study investigators, study site coordinators, and nurses involved in the study. The authors would like to thank The AstraZeneca Patient Partnership Program for its assistance in developing this article; from which seven patient reviewers were reimbursed at fair market value funded by AstraZeneca.
Financial disclosure
Capivasertib was discovered by AstraZeneca after a collaboration with Astex Therapeutics (and its partnership with the Institute of Cancer Research and Cancer Research Technology Limited). N.C. Turner: Consulting or Advisory Board Role: AstraZeneca, Lilly, Novartis, Pfizer, Roche/Genentech, GlaxoSmithKline, Repare Therapeutics, Relay Therapeutics, Gilead Sciences, Inivata, Guardant Health, Exact Sciences; Research Funding (Institutional): AstraZeneca, Pfizer, Roche/Genentech, Merck Sharp & Dohme, Invitae, Inivata, Personalis, Natera; Receipt of materials (Institutional): Bio-Rad, Guardant Health. M. Oliveira: Consulting or Advisory Board Role: AstraZeneca, Curio Science, Daiichi Sankyo/AstraZeneca, Gilead Sciences, iOne, iTeos Therapeutics, Lilly, Merck Sharp & Dohme, Pfizer, Relay Therapeutics, Roche, Seagen; Invited Speaker: AstraZeneca, Eisai, Gilead Sciences, Lilly, Medscape, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Seagen; Travel Grants: AstraZeneca, Eisai, Gilead Sciences, Pierre Fabre. S.J. Howell: Consulting or Advisory Board Role: Pfizer, Lilly; Honoraria: Lilly, Pfizer, Novartis, AstraZeneca; Research Funding (Institutional): Lilly, AstraZeneca; Travel Grants: Novartis. F. Dalenc: Honoraria (Institutional): Lilly, Gilead Sciences, AstraZeneca; Travel Grants: Daiichi Sankyo, Novartis, Gilead Sciences, Pfizer. J. Cortés: Consulting or Advisory Board Role: Celgene, Cellestia Biotech, AstraZeneca, Roche, Seagen, Daiichi Sankyo, ERYTECH Pharma, Polyphor, Athenex, Lilly, SERVIER, Merck Sharp & Dohme, GlaxoSmithKline, Leuko, Clovis Oncology, Bioasis Technologies, Boehringer Ingelheim, Ellipses Pharma, HiberCell, BioInvent, GEMoaB, Gilead Sciences, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, BridgeBio, BioNTech; Travel Grants: Roche, Pfizer, Eisai, Novartis, Daiichi Sankyo, Gilead Sciences, AstraZeneca, Merck Sharp & Dohme, Stemline Therapeutics; Stocks and Other Ownership Interests: MAJ3 Capital; Honoraria: Novartis, Eisai, Celgene, Pfizer, Roche, Samsung, Lilly, Merck Sharp & Dohme, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Stemline Therapeutics; Research Funding (Institutional): ARIAD, AstraZeneca, Baxalta, Bayer, Eisai, Guardant Health, Merck Sharp & Dohme, Pfizer, Puma Biotechnology, Queen Mary University London, Roche, PIQUR Therapeutics. H.L. Gomez: Consulting or Advisory Board Role: AstraZeneca; Honoraria: Roche, AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme Oncology, Tecnofarma, Novartis; Research Funding: Merck Sharp & Dohme Oncology. X Hu: Consulting or Advisory Board Role: AstraZeneca; Research Funding (Institutional): Merck Sharp & Dohme. K.L. Jhaveri: Consulting or Advisory Board Role: Novartis, Pfizer, AstraZeneca, Jounce Therapeutics, Synthon, Intellisphere, Bristol Myers Squibb, Genentech, AbbVie, Lilly, BluePrint Medicines, Seagen, Daiichi Sankyo, Biotheranostics, Sun Pharma Advanced Research Company, Taiho Oncology, Sanofi, Gilead Sciences, Scorpion Therapeutics; Research Funding (Institutional): Novartis, Genentech, Debiopharm Group, ADC Therapeutics, Pfizer, Novita Pharmaceuticals, Clovis Oncology, Lilly, Zymeworks, Immunomedics, Puma Biotechnology, VelosBio/Merck, AstraZeneca, Context Therapeutics, Scorpion Therapeutics, Blueprint Medicines; Travel Grants: Taiho Pharmaceutical, Jounce Therapeutics, Pfizer, AstraZeneca, Intellisphere, Lilly, Gilead Sciences, Genentech/Roche. S. Loibl: Consulting or Advisory Board Role (Institutional): AbbVie, AGO Kommission Mamma, Amgen, AstraZeneca, Bristol Myers Squibb, Celgene, Daiichi Sankyo, EirGenix, Gilead Sciences, GlaxoSmithKline, Lilly, Merck, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeutics, Roche, Sanofi, Seagen; Invited Speaker (Institutional): AstraZeneca, Daiichi Sankyo, Gilead Sciences, Novartis, Pfizer, Roche, Seagen, Stemline-Menarini; Invited Speaker: Medscape; Full or part-time Employment: GBG Forschungs GmbH; Licensing/Royalties (Institutional): VMscope GmbH; Principal Investigator: PI Aphinity; Research Funding (Institutional): AbbVie, AstraZeneca, Celgene, Daiichi Sankyo, Greenwich Life Sciences, Immunomedics/ Gilead Sciences, Molecular Health, Novartis, Pfizer, Roche. Y.H. Park: Consulting or Advisory Board Role (Institutional): AstraZeneca, Pfizer, Lilly, Gilead Sciences, Merck Sharp & Dohme, Eisai, Roche, Daiichi Sankyo, Menarini, Everest, Novartis; Research Funding (Institutional): Merck Sharp & Dohme, Pfizer, Roche, Novartis, AstraZeneca, Gencurix, Genome Insight; Honoraria: AstraZeneca, Pfizer, Lilly, Merck Sharp & Dohme, Roche, Daiichi Sankyo, Novartis, Gilead Sciences; Travel Grants: Gilead Sciences, Pfizer, AstraZeneca; Receipt of equipment, materials, drugs, medical writing, gifts or other services: Dong-A ST, Sanofi, Roche, Pfizer. J. Sohn: Research Funding (Institutional): Merck Sharp & Dohme, Roche, Novartis, Lilly, Pfizer, Daiichi Sankyo, AstraZeneca, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Seagen, Qurient Therapeutics, Dragonfly Therapeutics, Eikon Therapeutics, Gilead Sciences, Celcuity, Bristol Myers Squibb, HLB, Sermonix Pharmaceuticals, Olema Oncology, Hanmi Pharm, Ildong Pharmaceutical, Samyang Holdings. M. Toi: Consulting or Advisory Board Role: Athenex Oncology, Bertis, Bristol Myers Squibb, Daiichi Sankyo, Lilly, Kansai Medical Net, Terumo; Invited Speaker: AstraZeneca, Chugai, Daiichi Sankyo, Devicore Medical Japan, Eisai, Lilly, Exact Science, Kyowa-Kirin, Merck Sharp & Dohme, Nippon-Kayaku, Novartis, Pfizer, Shimadzu, Sysmex, Taiho Oncology, Takeda, Yakult; Research Funding (Institutional): AFI Technology, Astellas, AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Lilly, GL Science, Kansai Medical Net, Luxonus, Nippon-Kayaku, Pfizer, Sanwa Shurui, Shimadzu, Takeda, The Japan Breast Cancer Research Group Association, The Kyoto Breast Cancer Research Network Association, Yakult. E. Tokunaga: Honoraria: Eli Lilly, Daiichi Sankyo, AstraZeneca, Chugai. E. de Bruin, L. Grinsted, G. Schiavon, and A. Foxley: Full or part-time Employment: AstraZeneca; May hold Stocks and/or Shares: AstraZeneca. H. Rugo: Consulting or Advisory Board Role: Napo Pharmaceuticals, Mylan/Viatris, Eisai, Daiichi Sankyo; Research Funding (Institutional): Stemline Therapeutics, Ambrx. All other authors have declared no financial conflicts. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
M. Oliveira: Other, Personal, Educational activity: Libbs; Non-Financial Interests, Personal: SOLTI Breast Cancer Research, Member of Board of Directors. M. Toi: Leadership Role/Member of Board of Directors: Organisation for Oncology and Translational Research, The Japan Breast Cancer Research Group Association, The Japanese Onco-Cardiology Society, The Kyoto Breast Cancer Research Network Association, The Japanese Breast Cancer Society. All other authors have declared no conflicts of interest. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Medical writing and editorial assistance in the development of this publication was provided by Suzanne Patel, Ph.D., at BOLDSCIENCE Inc., funded by AstraZeneca.