Actively Recruiting
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
Led by West German Study Group · Updated on 2026-02-27
250
Participants Needed
7
Research Sites
222 weeks
Total Duration
On this page
Sponsors
W
West German Study Group
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females aged 18 years or older who are pre-, peri-, or post-menopausal, and males aged 18 years or older
- Pre-menopausal or peri-menopausal women must be amenable to treatment with a GnRH agonist and start it by Cycle 1, Day 1, continuing throughout the study
- Post-menopausal women defined by age, amenorrhea status, hormone levels, or bilateral oophorectomy
- Histologically confirmed hormone receptor-positive, HER2-negative breast cancer with specific receptor expression levels
- Metastatic or locally advanced breast cancer with radiological or objective evidence of progression
- Prior treatment with endocrine-based therapy and evidence of progression within specified timeframes
- Presence of alterations in PIK3CA, AKT1, or PTEN biomarkers
- Decision to start capivasertib treatment
- Signed informed consent before study procedures
- Female participants of childbearing potential must have a negative pregnancy test and use highly effective contraception or abstinence as specified
- Male participants must be surgically sterile, use effective contraception, or remain abstinent as specified
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no recent deterioration and life expectancy of at least 12 weeks
You will not qualify if you...
- No alterations in PIK3CA, AKT1, or PTEN biomarkers
- Previous participation in this study
- Current or recent participation in other blinded clinical trials with investigational treatments
- Disease burden making endocrine therapy unsuitable, including symptomatic life-threatening visceral disease
- History of drug or alcohol abuse within 1 year before screening
- Unresolved toxicities from prior therapy CTCAE Grade 2 or higher at treatment start
- Presence of leptomeningeal metastases
- Spinal cord compression or brain metastases unless stable and asymptomatic without steroid use
- Significant abnormalities in glucose metabolism, including HbA1c ≥8.0% at screening
- Inadequate bone marrow or organ function based on specific laboratory criteria
- Severe or uncontrolled systemic diseases, active infections including hepatitis B, C, HIV, or COVID-19
- Known coagulation disorders or use of anticoagulants preventing necessary injections
- Conditions affecting absorption of capivasertib, such as malabsorption or gastrointestinal diseases
- Prior bone marrow or solid organ transplant
- History of other primary malignancies or immunodeficiency syndromes
- Significant heart rhythm abnormalities or risk factors for QT prolongation
- Recent major cardiac events or heart failure NYHA grade 2 or higher
- Hypersensitivity to study drugs or related compounds
- Recent radiotherapy or major surgery within specified timeframes
- Cognitive or psychiatric conditions preventing informed consent
- Pregnancy or breastfeeding
- Participation in other blinded interventional studies
- More than 2 lines of endocrine therapy or more than 1 line of chemotherapy for advanced breast cancer
- Prior treatment with AKT, PIK3, or mTOR inhibitors, ngSERD (except fulvestrant), certain chemotherapies, immunotherapies, or drugs affecting CYP3A4 enzymes within specified washout periods
- Use of medications interfering with study drug safety or efficacy, including those associated with Torsade de Pointes or CYP3A4 inducers/inhibitors
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Not Yet Recruiting
2
CHC MontLegia
Liège, Belgium, 4000
Not Yet Recruiting
3
St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie
Cologne, North Rhine-Westphalia, Germany, 50935
Not Yet Recruiting
4
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45130
Not Yet Recruiting
5
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
Actively Recruiting
6
Universitätsklinikum Münster AöR Brustzentrum
Münster, North Rhine-Westphalia, Germany, 48149
Not Yet Recruiting
7
Champalimaud Clinical Centre
Lisbon, Portugal, 1400-038
Not Yet Recruiting
Research Team
R
Rico Laage, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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