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Tests treatment safety and results for Breast Cancer
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
ClinicalTrials.gov ID: NCT07281833
What this study is testing
What is Capivasertib?
Capivasertib is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form a. Pre-menopausal (and...
- Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. To...
- Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression...
- Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have: a...
- Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue\
You likely can't join if
- 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 treatment...
- A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral...
- Known history of drug or alcohol abuse within 1 year of screening
See the full eligibility criteria
Who can join
- Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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 treatment 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
- 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: a. HbA1c ≥8.0% (63.9 mmol/mol) at screening. Note: for any patient with evidence of impaired glucose control or insulin...
- 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 \ 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 \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 treatment 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...
- 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...
- Any concomitant medication that may interfere with capivasertib or fulvestrant safety and how well it works based on the Investigator´s Brochure of capivasertib and the prescribing information of fulvestrant and local...
The study team makes the final eligibility decision.
Where it's taking place
- Anderlecht, Belgium
- Liège, Belgium
- Cologne, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Mönchengladbach, North Rhine-Westphalia, Germany
- Münster, North Rhine-Westphalia, Germany
- Lisbon, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anderlecht, Belgium; Liège, Belgium; Cologne, North Rhine-Westphalia, Germany; Essen, North Rhine-Westphalia, Germany; Mönchengladbach, North Rhine-Westphalia, Germany; Münster, North Rhine-Westphalia, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.