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New treatment option for CCCA Assessed by Ki67 Drop Below <2.7% From Baseline
Official title Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
ClinicalTrials.gov ID: NCT06607757
What this study is testing
What is Capivasertib?
Capivasertib is an investigational medicine, given as an once-daily, being studied as a potential treatment for ccca assessed by ki67 drop below <2.7% from baseline.
Also referred to as Truqap.
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 multicenter, prospective, open-label, randomized phase II study to evaluate the CCCA assessed by Ki67 drop below \<2.7% from baseline to week 2 (window of opportunity) and to week 10 with capivasertib plus fulvestrant compared with fulvestrant alone as neoadjuvant treatment for primary high-risk lobular breast cancer patients. 120 patients will be randomized to receive: \- Capivasertib (400 mg po twice daily d1-4 followed by 3 days off) for 2 weeks followed by capivasertib (400 mg po twice daily d1-4 followed by 3 days off) and fulvestrant (500 mg i.m.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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, women only
You may be able to join if
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and...
- Postmenopausal women with age at diagnosis ≥ 18 years. Postmenopausal status is defined as:
- Age ≥60 years
- Age \<60 years and amenorrhea for at least 12 continuous months with no identified cause other than menopause
- Bilateral oophorectomy Negative pregnancy test (urine or serum) within 14 days prior to randomization for all postmenopausal women 50 years of age or...
You likely can't join if
- Female patients of childbearing potential.
- Excisional biopsy or lumpectomy performed prior to study entry.
- Surgical axillary staging procedure including sentinel lymph node biopsy prior to randomization. Exceptions: FNA or core biopsy of an axillary lymph...
- Any previous treatment including endocrine therapy, chemotherapy, radiotherapy or targeted therapy (including AKT inhibitor or PIK3 inhibitor) for...
- Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol.
See the full eligibility criteria
Who can join
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and followup, and documented according to the local regulatory requirements.
- Postmenopausal women with age at diagnosis ≥ 18 years. Postmenopausal status is defined as:
- Age ≥60 years
- Age \<60 years and amenorrhea for at least 12 continuous months with no identified cause other than menopause
- Bilateral oophorectomy Negative pregnancy test (urine or serum) within 14 days prior to randomization for all postmenopausal women 50 years of age or younger without bilateral oophorectomy
- Unilateral or bilateral primary untreated lobular invasive carcinoma of the breast. In case of bilateral breast cancer, both sides must be lobular; the lead tumor has to be defined by the investigator based on the for...
- Willingness and ability to provide archived formalin fixed paraffin embedded (FFPE) tissue block from core biopsy before the start of neoadjuvant therapy.
- Centrally confirmed HER2-negative (IHC score 0-1+ or ISH negative according to ASCO/CAP guideline) and HR-positive (≥10% positive stained cells) disease, assessed on the core of diagnostic biopsy. Ki67% \>10% is...
- Patients with invasive lobular breast cancer at high risk for recurrence defined as cT1c and clinical nodal involvement (cN+) or ≥ cT2 disease (irrespective of nodal involvement).
- No clinical evidence of distant metastases.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
- The patient must be accessible for scheduled visits, treatment, and followup.
- Normal cardiac function must be confirmed according to local guidelines.
- Laboratory requirements: Hematology
- Absolute neutrophil count (ANC) ≥1.5 x 109 / L
- Platelets ≥100 x 109 / L
- Hemoglobin ≥10 g/dL (≥6.2 mmol/L) Hepatic function
- Total bilirubin \<1.25x ULN
- AST and ALT \<=1.5x ULN
- Alkaline phosphatase \<=2.5x ULN Glucose Metabolism
- HbA1c \<8.0% (63.9 mmol/mol) Renal Function
- Creatinine \<1.25x ULN or creatinine clearance ≥50 ml/min (if creatinine is above ULN according to Cockroft-Gault)
- Complete staging work-up prior to the initiation of neoadjuvant therapy as per standard recommendations.
What rules you out
- Female patients of childbearing potential.
- Excisional biopsy or lumpectomy performed prior to study entry.
- Surgical axillary staging procedure including sentinel lymph node biopsy prior to randomization. Exceptions: FNA or core biopsy of an axillary lymph node.
- Any previous treatment including endocrine therapy, chemotherapy, radiotherapy or targeted therapy (including AKT inhibitor or PIK3 inhibitor) for the currently diagnosed breast cancer.
- Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol.
- Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort).
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism...
- Any contraindication for fulvestrant.
- Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.
- Patients with a history of any malignancy are ineligible with the following exceptions:
- Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy except for breast cancer.
- CIS of the cervix, basal cell and squamous cell carcinomas of the skin.
- History of type I or type II diabetes mellitus requiring insulin.
- Severe and relevant co-morbidity that would interact with the application of study drugs or the participation in the study, including cerebrovascular incident including transient ischemic attack, or symptomatic...
- Known medically history of HIV infection, tuberculosis, or hepatitis B.
- History of and/or active cardiac disease that would preclude the use of study treatments. This includes but is not confined to any of the following cardiac criteria:
- Clinically significant cardiac dysfunction including heart failure (NYHA II-IV), active ventricular arrhythmias requiring medication or arrhythmias requiring a pacemaker, and history of a myocardial infarction within 6...
- Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs.
- Increased risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled electrolyte disorders (e.g., hypocalcemia, hypokalemia, or hypomagnesemia), potential for torsades de pointes...
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving therapy.
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results (such as severe or uncontrolled systemic diseases...
- 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.
- Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Augsburg, Germany
- Berlin, Germany
- Bielefeld, Germany
- Bremen, Germany
- Cologne, Germany
- Cottbus, Germany
- Dortmund, Germany
- Essen, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Homburg, Germany
- Kassel, Germany
- Leipzig, Germany
- Münster, Germany
- Oldenburg, Germany
- Ravensburg, Germany
- Rostock, Germany
- Schweinfurt, Germany
- Stendal, Germany
+ 5 more site(s).
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augsburg, Germany; Berlin, Germany; Bielefeld, Germany; Bremen, Germany; Cologne, Germany; Cottbus, Germany and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.