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Rx Prescripttion Only-YMYL Medical Content
Capivast 200 mg
Capivasertib 200mg tablets – Everest Pharmaceuticals Ltd.
Approved, in combination with fulvestrant, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, whose disease progressed on or after an endocrine-based regimen.
- Clinical outcomes at a glance
7.3 mo
Median progression-free survival vs 3.1 mo with fulvestrant alone (CAPItello-291, biomarker-altered group)
2x+
Reduction in risk of disease progression vs fulvestrant alone
AKT
First-in-class AKT inhibitor approved for this biomarker population
4-on/3-off
Weekly intermittent dosing schedule with fulvestrant
- Am I a candidate? — Take Decesion
1
Confirm PIK3CA, AKT1, or PTEN alteration status
Requires tumor tissue or blood-based testing with an FDA-approved companion diagnostic (such as FoundationOne CDx) to detect at least one of these alterations.
2
Confirm HR-positive, HER2-negative status and prior endocrine therapy
Used after disease progression on or after an aromatase inhibitor or other endocrine-based regimen, in combination with fulvestrant.
3
Review blood sugar and skin condition history
Pre-existing diabetes, prediabetes, or history of severe skin reactions significantly affects the risk-benefit discussion and monitoring plan.
4
Discuss your goals of care
Weigh the progression-free survival benefit against the intermittent dosing schedule, diarrhea management plan, and blood sugar/skin monitoring requirements.
Important safety information: Capivasertib can cause severe diarrhea that may require dose interruption, reduction, or antidiarrheal treatment. It can also cause hyperglycemia (high blood sugar), which may be severe in patients with diabetes or prediabetes, and severe skin reactions including Stevens-Johnson syndrome in rare cases. Lung inflammation (pneumonitis) has also been reported. Blood sugar and skin should be monitored closely, especially in the first weeks of treatment.
- common side effects to know
- Diarrhea (~72%)
- Rash (~38%)
- Nausea / fatigue
- Mild blood sugar elevation (~21%)
- Severe diarrhea / dehydration
- Severe hyperglycemia / skin reactions
- Trust & expertise
- FDA Approved 2023
- EMA Review Ongoing
- NCCN Breast Cancer Guidelines
- CAPItello-291 Phase III RCT
MD
Medical Oncologist Review
Board-certified oncologist · 12+ years in thoracic malignancies
“Capivasertib opened a new pathway for patients whose tumors carry PIK3CA, AKT1, or PTEN alterations and who’ve progressed on endocrine therapy. The doubling of progression-free survival in this biomarker-selected group is meaningful, but the diarrhea and blood sugar effects need proactive management from the first dose — patients who are prepared for the on/off schedule and know what to watch for tend to stay on treatment longer.”
Content reviewed against FDA prescribing information, NCCN Guidelines v2.2024, and published Phase III trial data. Last updated June 2026.
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These steps help you have an informed conversation. A confirmed EGFR mutation result is the starting point for any treatment decision.
Questions to ask my healthcare provider
Here are key questions to bring to your oncologist — since capivasertib is biomarker-driven and combination therapy with a distinctive dosing schedule, the questions naturally cluster around those three areas.
Before confirming this combination as your treatment
- Has my tumor been tested for PIK3CA, AKT1, and PTEN alterations — and which one(s) do I have?
- Was this testing done on a recent tumor sample or an older one? Does the timing of the sample matter for how reliable the result is?
- Why is capivasertib plus fulvestrant being recommended now — because of progression on my current endocrine therapy, or for another reason?
- Are there other options for my biomarker profile, such as alpelisib if I have a PIK3CA mutation specifically?
About the dosing schedule — this is unusual and worth understanding clearly
- Can you walk me through the 4-days-on, 3-days-off weekly schedule — which specific days, and does it need to align with my fulvestrant injection schedule?
- How many tablets do I take, and at what times of day? Does it matter if I take it with or without food?
- What happens if I miss a dose, or if I’m late taking it on one of the “on” days?
- How is fulvestrant given, and how do the two treatments fit together logistically (injection visits vs. daily pills at home)?
About diarrhea — the most common side effect
- Should I start an anti-diarrheal medication proactively, or only if symptoms develop?
- At what point does diarrhea become serious enough to interrupt or reduce my dose?
- What does “staying hydrated” practically look like, and are there warning signs of dehydration I should watch for?
About blood sugar monitoring
- Do I have any history of diabetes or prediabetes, and how does that change my monitoring plan?
- How often will my blood sugar be checked, especially early on?
- What symptoms of high blood sugar (excessive thirst, frequent urination, fatigue, confusion) should prompt me to call you or seek urgent care?
About skin reactions
- What does a “normal” rash from this medication look like versus something more serious?
- If I notice blistering, peeling skin, or sores in my mouth, how quickly should I seek care?
About monitoring overall
- What’s the schedule for scans to check whether this combination is working, and how soon might we see a response?
- What blood tests will be done regularly, and how often?
- Will any other specialists be involved in my care — for example, an endocrinologist if blood sugar issues come up?
About my specific situation
- How does this combination interact with my other current medications?
- If I’m of childbearing potential, what precautions are needed?
- Does my kidney or liver function affect dosing?
About the longer road
- If this combination stops working, what’s typically considered next?
- Is there a clinical trial I should know about, either now or for later?
- Are there patient assistance programs through AstraZeneca if cost becomes a concern?
A practical tip: Because the 4-on/3-off schedule doesn’t line up with a typical week, ask if your care team has a printed calendar template for this specific regimen — many patients find a physical or phone calendar marking “on” and “off” days essential for the first few cycles until the pattern becomes automatic.
compare with other therapies
Alpelisib and capivasertib both target the same broad signaling pathway (PI3K-AKT-mTOR) and are both combined with fulvestrant for HR-positive, HER2-negative advanced breast cancer — but they hit different points in that pathway, and their biomarker eligibility and side-effect profiles diverge in important ways.
Where each drug sits in the pathway
| Alpelisib (Piqray) | Capivasertib (Truqap) | |
|---|---|---|
| Target | PI3Kα (upstream) | AKT (downstream of PI3K) |
| Approved | 2019 | 2023 |
| Pivotal trial | SOLAR-1 | CAPItello-291 |
| Biomarker required | PIK3CA mutation only | PIK3CA, AKT1, or PTEN alteration |
| Companion diagnostic | therascreen PIK3CA RGQ PCR Kit | FoundationOne CDx (broader panel) |
This is the most important structural difference: alpelisib is PIK3CA-specific, while capivasertib covers a wider set of patients — including those with AKT1 mutations or PTEN loss who wouldn’t qualify for alpelisib at all. If you have a PIK3CA mutation specifically, both are on the table; if you have AKT1 or PTEN alterations instead, capivasertib is the one with an approved indication.
Efficacy — different trials, similar magnitude of benefit
| Alpelisib + fulvestrant (SOLAR-1) | Capivasertib + fulvestrant (CAPItello-291) | |
|---|---|---|
| Population | PIK3CA-mutated only | PIK3CA, AKT1, or PTEN-altered |
| Median PFS | 11.0 months vs 5.7 months (fulvestrant alone) | 7.3 months vs 3.1 months (fulvestrant alone) |
Both roughly doubled progression-free survival compared to fulvestrant alone in their respective trial populations. Importantly, these weren’t head-to-head trials against each other, and the patient populations and prior-treatment histories differed — so the raw numbers above shouldn’t be read as “alpelisib works better.” The comparison that matters most is each drug versus its own control arm, not the two drugs against each other.
Dosing schedule — a major practical difference
| Alpelisib | Capivasertib | |
|---|---|---|
| Frequency | Once daily, continuous (no breaks) | Twice daily, 4 days on / 3 days off each week |
| With food? | Taken with food | Can vary — confirm with your prescriber |
Alpelisib’s continuous daily schedule is simpler to remember but means no breaks from side effects. Capivasertib’s intermittent schedule gives the body recovery days each week, which may help with side effect management, but requires more careful tracking of which days are “on.”
Side effects — hyperglycemia is the key differentiator
| Alpelisib | Capivasertib | |
|---|---|---|
| Hyperglycemia | Very prominent — roughly two-thirds of patients affected, often requiring proactive management (sometimes with metformin started alongside) | Present but generally less severe than alpelisib |
| Diarrhea | Common | More prominent (~72% of patients) |
| Severe skin reactions | Boxed warning — includes Stevens-Johnson syndrome risk | Warning present, but not boxed |
| Severe hypersensitivity reactions | Boxed warning | Not specifically highlighted |
| Pneumonitis | Warning present | Reported, less emphasized |
The practical takeaway: alpelisib’s hyperglycemia risk is high enough that many oncology teams start a glucose-lowering medication preventively, even before blood sugar rises — this is a more proactive intervention than typically needed with capivasertib. On the other hand, capivasertib’s diarrhea tends to be more frequent and the dominant day-to-day issue.
How the choice typically plays out
- If you have a PIK3CA mutation and no AKT1/PTEN alteration, both drugs are potential options, and the discussion often centers on which side-effect profile fits you better — for example, someone with diabetes or prediabetes might be steered away from alpelisib given its hyperglycemia risk, while someone prone to GI issues might find capivasertib’s diarrhea more challenging.
- If you have an AKT1 mutation or PTEN alteration without a PIK3CA mutation, capivasertib is the one with an approved indication covering your biomarker — alpelisib wouldn’t apply.
- Sequencing — whether one could be used after the other if the first stops working — is an evolving area, and because capivasertib is newer, there’s less established real-world experience with this specific sequence than there is for other drug pairs we’ve discussed.
Bottom line
These aren’t simply “older vs newer” alternatives the way some of our other comparisons have been — they target different points in the same pathway, have different biomarker eligibility, and have meaningfully different side-effect emphases (hyperglycemia-dominant for alpelisib, diarrhea-dominant for capivasertib). Your specific biomarker result (PIK3CA vs AKT1 vs PTEN), your metabolic health history, and your oncologist’s experience with managing each drug’s distinctive side effects will all shape which one — if either — fits your situation.
How does testing work
PIK3CA, AKT1, and PTEN testing follows a similar logic to the EGFR and FLT3 testing we’ve discussed — confirming a specific molecular alteration before a targeted therapy can be prescribed — but the testing landscape here is a bit more fragmented because it spans three different genes with three different types of alterations.
What’s being tested
All three genes sit on the PI3K-AKT-mTOR signaling pathway, which regulates cell growth and survival. When this pathway becomes overactive due to mutations, cancer cells can grow and survive treatment more easily.
PIK3CA mutations are the most common of the three, found in roughly 40% of HR-positive breast cancers. These are typically “hotspot” mutations — specific, well-characterized changes at known positions in the gene (such as H1047R, E545K, or E542K).
AKT1 mutations are less common, with one specific mutation (E17K) being the most clinically relevant.
PTEN is different in nature — it’s a tumor suppressor gene, so “alterations” usually mean loss of function, either through mutations, deletions, or loss of the protein it produces. This is conceptually different from PIK3CA/AKT1, where the mutations activate the gene rather than disabling it.
Sample source
Two options are used, often interchangeably depending on availability:
Tumor tissue — either an archival sample from a prior biopsy/surgery, or a fresh biopsy if needed. This allows for both DNA sequencing and, for PTEN specifically, immunohistochemistry (IHC) to directly visualize whether the protein is present or absent in tumor cells.
Liquid biopsy (blood-based ctDNA testing) — increasingly used, especially for PIK3CA mutations, since circulating tumor DNA can be detected even when a fresh tissue sample isn’t practical to obtain. This was actually validated as an acceptable testing method in the capivasertib approval trial.
How the lab analyzes it
- PCR-based assays — designed to detect specific, known hotspot mutations (this is how alpelisib’s companion diagnostic works, focused specifically on PIK3CA)
- Next-generation sequencing (NGS) panels — broader tests that can detect PIK3CA, AKT1, and PTEN alterations simultaneously, along with other relevant genes (this is the approach used for capivasertib’s companion diagnostic, which is why it covers more biomarkers than alpelisib’s)
- Immunohistochemistry (IHC) — used specifically for PTEN, staining tumor tissue to check whether the PTEN protein is being produced normally or is absent
The shift toward NGS panels matters because a single test can now answer the question for all three genes at once, rather than needing separate tests run sequentially.
Timeline
Tissue-based NGS results typically take 1–3 weeks. Liquid biopsy (ctDNA) results often return faster, generally 1–2 weeks, though turnaround varies by lab.
What the result means for treatment
| Result | What it typically means |
|---|---|
| PIK3CA mutation detected | Both alpelisib and capivasertib (with fulvestrant) become potential options |
| AKT1 mutation (e.g., E17K) detected, no PIK3CA mutation | Capivasertib is the relevant approved option; alpelisib doesn’t apply |
| PTEN alteration/loss detected, no PIK3CA mutation | Capivasertib is the relevant approved option; alpelisib doesn’t apply |
| None of the three detected | These targeted combinations aren’t indicated; other treatment lines (different endocrine therapy, CDK4/6 inhibitors if not already used, chemotherapy) are considered |
A practical nuance
Because PTEN testing can involve both DNA-level changes and protein expression loss, and because labs vary in which methods they use for which gene, it’s worth specifically asking your oncologist which test was run and which of the three genes it covered — a tissue sample tested only for PIK3CA hotspots (an older or narrower test) wouldn’t tell you anything about AKT1 or PTEN status, which could matter if the PIK3CA result comes back negative.
Medical disclaimer: This page is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Osimertinib is a prescription medication that must only be used under the supervision of a qualified oncologist. Clinical outcomes data is drawn from published Phase III trials; individual results vary. Always consult your healthcare provider and refer to the full prescribing information before making any treatment decisions. Emergency: call your local emergency services or poison control immediately if you experience serious adverse effects.
