OncoMatch/Clinical Trials/NCT07281833
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
Is NCT07281833 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capivasertib for breast cancer.
Treatment: Capivasertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA any eligible alteration
Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue
Required: AKT1 any eligible alteration
Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue
Required: PTEN any eligible alteration
Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue
Required: ESR1 overexpression (ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or Allred IHC score ≥3/8)
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
Required: HER2 (ERBB2) wild-type (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)
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
Allowed: PR (PGR) overexpression
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine-based therapy — adjuvant, neoadjuvant, locally advanced, or metastatic
Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have: a. 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
Cannot have received: AKT inhibitor
Prior treatment with any of the following: AKT, PIK3 and mTOR inhibitors
Cannot have received: PI3K inhibitor
Prior treatment with any of the following: AKT, PIK3 and mTOR inhibitors
Cannot have received: mTOR inhibitor
Prior treatment with any of the following: AKT, PIK3 and mTOR inhibitors
Cannot have received: ngSERD
Exception: prior treatment with fulvestrant (=SERD) is allowed
Prior treatment with ngSERD (Note: prior treatment with fulvestrant (=SERD) is allowed!)
Cannot have received: nitrosourea
Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation
Cannot have received: mitomycin C
Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation
Cannot have received: chemotherapy
Exception: adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for mBC
More than 1 line of chemotherapy for inoperable locally advanced or mBC
Cannot have received: endocrine-based therapy
More than 2 lines of endocrine-based therapy for inoperable locally advanced or mBC
Cannot have received: immunotherapy
Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation
Cannot have received: immunosuppressant medication
Exception: other than corticosteroids
Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation
Cannot have received: anticancer agents
Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation
Cannot have received: radiation therapy
Radiotherapy within 14 days prior to first dose of capivasertib
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; haemoglobin ≥9 g/dL (≥5.59 mmol/L); any blood transfusion must be >14 days prior to determination of haemoglobin ≥9 g/dL
Kidney function
Creatinine ≤1.5x ULN concurrent with creatinine clearance ≥50 mL/min (measured or calculated by Cockcroft and Gault equation); creatinine clearance is only required when creatinine is >1.5x ULN
Liver function
ALT and AST ≤2.5x ULN if no demonstrable liver metastases or ≤5x ULN in the presence of liver metastases; total bilirubin ≤1.5x ULN (Patients with confirmed Gilbert's syndrome may be included)
Cardiac function
Mean resting corrected QT interval ≤470 ms, obtained from triplicate ECGs performed at screening; no history of QT prolongation associated with other medications that required discontinuation; no congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives; no symptomatic or uncontrolled arrhythmia (exceptions for controlled atrial fibrillation or arrhythmias controlled by pacemakers)
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: Absolute neutrophil count <1.5 × 10^9/L; Platelet count <100 × 10^9/L; Haemoglobin <9 g/dL (<5.59 mmol/L). ALT and AST >2.5x ULN if no demonstrable liver metastases or >5x ULN in the presence of liver metastases; total bilirubin >1.5x ULN. Creatinine >1.5x ULN concurrent with creatinine clearance <50 mL/min. 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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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