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Oestrogen-receptor positive breast cancers account for over 70% of all breast cancers. Endocrine therapies targeting oestrogen have been standard treatment for several decades, and while effective, these cancers can become resistant to treatment. CDK4/6 inhibitors have been effective in combatting endocrine resistance, when used alongside endocrine therapy, but resistance to treatment with CDK4/6 inhibitors can also develop in some ER+ cancers. It is thought that the PI3K pathway (important in cell growth and survival) can become very active in cancer cells because of mutations in the PIK3CA gene, and that this pathway may be important when resistance to CDK4/6 inhibitors and endocrine therapy develops.
This trial hopes to determine whether individuals with breast cancers that have the PIK3CA mutation will be more likely to benefit from treatment with alpelisib (a PIK3CA inhibitor), in combination with fulvestrant, compared to standard treatment with capecitabine.
Who is it for?
This trial is open to both women and men diagnosed with ER+, HER2- negative breast cancer that has returned after treatment with a CDK4/6 inhibitor (such as ribociclib, palbociclib, abemaciclib).
The CAPTURE clinical trial will screen approximately 400 patients with ER+, HER2- breast cancer via a blood test for the PIK3CA gene mutation in ctDNA. Those participants who have a confirmed PIK3CA gene mutation will be randomised to receive alpelisib and fulvestrant (Arm A) or the standard treatment capecitabine (Arm B).
Participants will have regular blood tests to see if the level of ctDNA changes during treatment. Participants will continue treatment until documented disease progression. The final study visit occurs 28 days after the last dose of study treatment. Treatment after the end of the study will be decided by the participant and their primary physician.
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