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Breast CancerPhase 3CAPIcornNCT07281833

Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

A Phase 3 study testing Capivasertib in people with Breast Cancer and HR-positive Breast Cancer, run by Women's Cancer Study Group GmbH at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment. The goal of this study is 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capivasertib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
16 sitesin 3 countries
Study dates
27 Nov 2025to Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form
  • Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenable to treatment with an GNRH agonist. Patients are to have commenced concomitant treatment with GNRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue it for the duration of the study.
  • Post-menopausal women are defined as: i. aged ≥60 years of age, OR ii. aged <60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, OR iii. documented bilateral oophorectomy.
  • Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
  • Therefore, tumours must be:
  • ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3/8, b. Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3/8; or progesterone receptor negative defined as <1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2/8; or progesterone receptor unknown, and c. HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.
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  • Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).
  • Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have:
  • Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET, OR b. Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy).
  • Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue*
  • Decision to newly initiate capivasertib
  • Informed consent provided by patient prior to participation in the trial and before initiation of any study-specific measures
  • A. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally, - surgically sterile, - carry an intrauterine device (combined with a barrier method),
  • having received a bilateral tubal ligation/occlusion (combined with a barrier method),
  • or using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of capivasertib / GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.
  • Total/true abstinence When the patient refrains from any form of sexual intercourse and this is in line with their usual and/or preferred lifestyle; this must continue for the duration of the study and for 3 months after the last dose of capivasertib/ GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.
  • Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy
  • Hormonal contraception is not acceptable.
  • 8. B. Male patients must either be
  • surgically sterile
  • or using an highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 months after the last dose of capivasertib/ GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.
  • Sexually abstinent men (i.e., refraining from heterosexual intercourse during the entire study duration) must continue for 4 months after the last dose of capivasertib/ GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.
  • Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide upon entering the study and until 4 months after the last dose of capivasertib and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.
  • Highly effective methods of contraception should be considered in female partners of men taking capivasertib plus fulvestrant who are of childbearing potential.
  • 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks
  • A list of eligible alterations and test procedures is provided in the protocol.

Who cannot join

  • Patients eligible for inclusion in this study must not meet any of the following criteria:
  • Absence of an alteration in the PIK3CA/AKT1/PTEN biomarkers
  • Previous enrolment in the present study
  • Participation in another clinical study with any investigational medicinal product and still on IMP treatment or have participated in an interventional study that remains blinded
  • A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life threatening in the short-term)
  • Known history of drug or alcohol abuse within 1 year of screening
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  • Except for alopecia, any unresolved toxicities from prior therapy CTCAE Grade ≥2 at the time of starting study treatment
  • Leptomeningeal metastases
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable, and not requiring steroids within 4 weeks prior to study treatment initiation
  • Clinically significant abnormalities of glucose metabolism as defined by any of the following:
  • HbA1c ≥8.0% (63.9 mmol/mol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count <1.5 × 109/L
  • Platelet count <100 × 109/L
  • Haemoglobin <9 g/dL (<5.59 mmol/L). [NOTE: any blood transfusion must be >14 days prior to the determination of a haemoglobin ≥9 g/dL (≥5.59 mmol/L)]
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) >2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or >5 × ULN in the presence of liver metastases
  • Total bilirubin >1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study)
  • Creatinine >1.5 × ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation); creatinine clearance is only required when creatinine is >1.5 × ULN
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection including tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), including those who have confirmed COVID 19 and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Screening for chronic conditions is not required.
  • Note: Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib
  • Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or subcutaneous injections of GNRH agonist (if applicable)
  • Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
  • Previous allogenic bone marrow or solid organ transplant
  • History of another primary malignancy
  • Known immunodeficiency syndrome
  • Mean resting corrected QT interval >470 ms, obtained from triplicate ECGs performed at screening. History of QT prolongation associated with other medications that required discontinuation of that medication [Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.]
  • Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, hypokalaemia of Grade >1, potential for Torsades de Pointes, congenital long QT syndrome
  • Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris. Congestive heart failure New York Heart Association (NYHA) ≥grade 2.
  • History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and GNRH agonists (if applicable, i.e., concomitant GNRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or GNRH agonists (if applicable)
  • Radiotherapy within 14 days prior to first dose of capivasertib
  • Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
  • Evidence of dementia altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
  • Pregnancy or breastfeeding
  • Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded
  • More than 2 lines of endocrine-based therapy for inoperable locally advanced or mBC
  • More than 1 line of chemotherapy for inoperable locally advanced or mBC. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for mBC
  • Prior treatment with any of the following:
  • AKT, PIK3 and mTOR inhibitors
  • ngSERD (Note: prior treatment with fulvestrant (=SERD) is allowed!)
  • Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation
  • Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor
  • Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation.
  • Any concomitant medication that may interfere with capivasertib or fulvestrant safety and efficacy based on the Investigator´s Brochure of capivasertib and the prescribing information of fulvestrant and local clinical guidelines, e.g., that are known to be associated with Torsade de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).

Trial locations and contacts

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Rico Laage, Dr. contact

02161566230

rico.laage@wsg-online.com

16 sites in 3 countries

Germany14 sites, 14 recruiting

  • St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie

    Cologne, North Rhine-Westphalia, 50935

    Julian Puppe, Dr.

    Anne-Katrin Oligmüller, Dr.

    Recruiting

  • Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide

    Cologne, 51067

    Myriam Vincent

    Fatima Kourisna

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45130

    Clarissa Judith Piotrowsky

    Svenja Krüger

    Recruiting

  • Evanglisches Kliniken Essen Mitte

    Essen, 45136

    Sherko Kümmel, Prof. Dr.

    Oliver Braune

    Recruiting

  • AGAPLESION Markus Krankenhaus

    Frankfurt, 60431

    Marc Thill, Prof. Dr.

    Madeleine Modrow

    Recruiting

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

    Christian Schem, Prof. Dr.

    Kathleen Bever

    Recruiting

  • Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz

    Hildesheim, 31134

    Christoph Uleer, Dr.

    Andrea Meyer-Kühn

    Recruiting

  • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

    Mönchengladbach, North Rhine-Westphalia, 41061

    Katja Krauß, Dr.

    Carolin Sydlik

    Recruiting

  • Klinikum der Universität München

    München, 80336

    Rachel Würstlein, Dr.

    Beate Rank

    Recruiting

  • Rotkreuzkliniken München

    München, 80637

    Anne Andrulat, Dr.

    Harry Reisch

    Recruiting

  • Universitätsklinikum Münster AöR Brustzentrum

    Münster, North Rhine-Westphalia, 48149

    Joke Tio, Dr. med.

    Carl Christian Opitz, Dr. med.

    Not yet recruiting

  • MVZ Media Vita (St. Franziskus-Hospital Münster)

    Münster, 48145

    Stefanie Wiebe, Dr.

    Sarah Damerau

    Recruiting

  • MKS St. Paulus GmBH Mariankrankenhaus

    Schwerte, 58239

    Sarah Wetzig

    Kristin Backhaus

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89075

    Sabine Heublein, Prof. Dr.

    Heike Fabing

    Recruiting

Other trials in Germany

Belgium1 site, 1 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Evandro de Azambuja, Dr.

    Evandro de Azambuja, Dr.

    Recruiting

Other trials in Belgium

Portugal1 site, 1 recruiting

  • Champalimaud Clinical Centre

    Lisbon, 1400-038

    Helena Gouveia, Dr.

    Helena Gouveia, Dr.

    Recruiting

Other trials in Portugal

About this study

Official title: An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment.

The goal of this study is

Read more
  1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time "on treatment" with capivasertib.
  2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.

There is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..

Participants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.

Read the detailed description

Trial type: Interventional Clinical indication: HR+/HER2- advanced breast cancer under progress

IMP: capivasertib (CAPI) AxMP: fulvestrant (FULV) AxMP: GnRH agonists (GnRH)

Dose and route of administration: IMP: 2x400 mg, peroral, for 4 days, followed by 3 days off treatment AxMP FULV: 500 mg, intramuscular, every 28 days AxMP GnRH-agonist: according to SmPC of the medicinal product used

Treatment arm 1

  • capivasertib (CAPI)
  • with and without eHealth support (CANKADO PRO-active)

Type of control:

  • No active control or comparator for Arm 1-treatment
  • Historical study data from CAPItello-291 study

Trial blinding: Not applicable; open-label Number of trial participants: N=250 patients (Screening of about 600 patients expected to recruit 250 patients with alterations of the PIK3CA/AKT1/PTEN biomarkers)

Estimated enrolment period: 24 months Estimated duration of trial: Recruitment interval (expected 24 months) plus minimum 36 months follow-up (after LPI).

  • Expected FPI: Q4 / 2024 - Q1 / 2025
  • EOS: Q1 / 2030 Duration of participation: All patients will be followed-up from time point of inclusion until global End of Study (EOS) or death, whatever happens first.

Length of study treatment per patient: Capivasertib (CAPI) will be started after inclusion in the study and be administered until next progression, death, until any unbearable medical or other reason occurs that requires end of study for the patient, or global End of Study (EOS), whatever happens first.

Being tested
Capivasertib
Keywords
breast cancer, advanced, metastatic, metastatic, progression, HR+, HER2-, capivasertib, eHealth, ePRO
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapivasertibDrug

    2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Study groups in NCT07281833
Study groupRoleWhat they receive
CapivasertibExperimental2x400 mg, peroral, for 4 days, followed by 3 days off treatment
Receives: Drug: Capivasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Superiority* of TTNT1 in patients receiving capivasertib compared to an evidence-based "standard TTNT1 curve" for patients without capivasertib.

    • Statistical comparison by survival modelling of time on treatment including competing risks.
    • Standard curve is derived from placebo + fulvestrant arm of CAPItello-291 trial and corresponds to 17% remaining "on-treatment" at 12 months.
    • Stratification by eHealth support vs. no eHealth support

    Measured: Last-patient-in plus 12 months

  2. Superiority* of PRO-adherence compared to non-adherence regarding TTDQoL (aka DQoL-free interval).

    • The event DQoL is defined in terms of a 10-point drop of the FACT-G score compared to baseline.
    • A patient is classified here as "PRO-non-adherent" if she does not use CANKADO on 60 or more of the first 90 days, otherwise as "PRO-adherent".

    Measured: through study completion, after 170 total DQoL-events occurred

Secondary outcomes (4)

  1. Progression-free survival (PFS): defined by either: • evidence of disease progression as assessed by treating physician or • death

    • To evaluate progression-free survival (PFS) from index date (CAPI initiation)

    Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months

  2. Overall survival (OS)

    • To evaluate overall survival (OS) from index date

    Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months

  3. Superiority of eHealth support (and summary statistics) regarding TTDQoL compared to patients entering the trial without eHealth support.**

    • To evaluate the impact of eHealth support (with or without PRO-adherence) compared to no eHealth support regarding the DQoL-free interval (TTDQoL as defined above)

    Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months

  4. Evaluation of prophylactic and reactive treatments for AESI management

    • To characterise the management of AESIs

    Measured: Treatment start until end of study, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start27 Nov 2025
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multicentre, interventional, prospective, one-armed, open-label, phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment The study will consist of: A. a recruitment phase, 24 months, during which the patients are screened and enrolled B. a study treatment and follow-up phase of up to 60 months until end of study, dependent on timepoint of enrolment in the study.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07281833
Sponsor's protocol ID
WSG-AM14 (CAPIcorn)
Acronym
CAPIcorn
Status last verified
Aug 2026
First submitted
19 Nov 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capivasertib in people with Breast Cancer and HR-positive Breast Cancer, run by Women's Cancer Study Group GmbH at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, Belgium, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rico Laage, Dr. (02161566230, rico.laage@wsg-online.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superiority* of TTNT1 in patients receiving capivasertib compared to an evidence-based "standard TTNT1 curve" for patients without capivasertib. (time frame: Last-patient-in plus 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07281833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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