IPATASERTIB for Early breast cancer

Inclusion criteria

• {"criterion_text":"-Provision of written informed consent"}
• {"criterion_text":"-Ability of patient to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations"}
• {"criterion_text":"-Adequate bone marrow, renal, and hepatic function defined by laboratory tests"}
• {"criterion_text":"-Female and male patients with non-metastatic early (stage I-III) breast cancer aged ≥ 18 years"}
• {"criterion_text":"-Conducted neoadjuvant chemotherapy and surgery as well as conducted standard postneoadjuvant treatment +/- radiotherapy (standard according to German guidelines except Abemaciclib and Olaparib)*"}
• {"criterion_text":"-For patients with initially triple negative (TNBC) or HER2-positive breast cancer: Non-pCR defined as other than ypT0/is ypN0"}
• {"criterion_text":"-For patients with initially hormone receptor positive and HER2-negative breast cancer: NonpCR and CPS-EG score • ≥ 3 and ypN0, or • ≥ 2 and ypN+"}
• {"criterion_text":"-ECOG Performance Status ≤ 1"}
• {"criterion_text":"-Acute effects of any prior therapy resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade ≤ 1 except for adverse effects not constituting a safety risk by investigator judgement"}
• {"criterion_text":"-Postmenopausal or evidence of non-childbearing status. For women of childbearing potential negative urine pregnancy test at post-operative screening and baseline as well as highly effective forms of contraception have to be in place thereafter"}
• {"criterion_text":"-Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly effective method). These should be started immediately after signing the informed consent form and continued throughout the period of study treatment plus a substance-depending time period (see respective sub-protocol) for female patients and a substance-depending time period for male patients. Details on contraception and pregnancy testing for male and female patients (and if indicated their partners) under IMP treatment are described within the respective sub-protocol"}

Exclusion criteria

• {"criterion_text":"-Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 year"}
• {"criterion_text":"-Dementia or significant impairment of cognitive state"}
• {"criterion_text":"-Epilepsy requiring pharmacologic treatment"}
• {"criterion_text":"-Pregnancy and breast feeding"}
• {"criterion_text":"-Inability to take oral medication and gastrointestinal disorders likely to interfere with absorption of study medication"}
• {"criterion_text":"-Major surgery (any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered) within four weeks before screening and baseline excluding breast-tumor resection after neoadjuvant chemotherapy. Patients must have recovered from any effects of any major surgery"}
• {"criterion_text":"-Systemic chemotherapy or radiotherapy within four weeks or a longer period depending on the characteristics of the agents used"}
• {"criterion_text":"-Heart failure classified as New York Heart Association (NYHA) II/III/IV"}
• {"criterion_text":"-Severe obstructive or restrictive ventilation disorder"}
• {"criterion_text":"-Patients with clinically active tuberculosis"}
• {"criterion_text":"-Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug"}
• {"criterion_text":"-Concurrent severe, uncontrolled systemic disease that would place patient at undue risk or interfere with planned treatment"}
• {"criterion_text":"-Is taking or requiring the continued use of any of the prohibited concomitant medications listed in the respective subprotocols at baseline"}
• {"criterion_text":"-Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression or, superior vena cava syndrome"}
• {"criterion_text":"-Concurrent participation or previous treatment within 30 days in another interventional clinical trial"}
• {"criterion_text":"-Persistent toxicity (≥ Grade 2 according to NCI CTCAE v5.0 caused by previous cancer therapy, excluding alopecia"}
• {"criterion_text":"-Clinical signs of active infection (> Grade 2 according NCI CTCAE v5.0)"}
• {"criterion_text":"-History of or newly diagnosed human immunodeficiency virus (HIV) infection and immunocompromised patients"}
• {"criterion_text":"-Active Hepatitis A virus infection"}
• {"criterion_text":"-Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening , are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines"}
• {"criterion_text":"-Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA"}

Primary endpoints

• {"endpoint_text":"-IDFS* of patients four years after surgery overall (*IDFS: time from surgery to whatever comes first a) ipsilateral invasive breast tumor recurrence, b) local/regional invasive breast cancer recurrence, c) distant recurrence, d) death attributable to any cause incl. breast cancer, e) contralateral invasive breast cancer or f) Second primary non-breast invasive cancer)","definition_or_measurement_approach":"IDFS: time from surgery to whatever comes first a) ipsilateral invasive breast tumor recurrence, b) local/regional invasive breast cancer recurrence, c) distant recurrence, d) death attributable to any cause including breast cancer, e) contralateral invasive breast cancer or f) second primary non-breast invasive cancer; assessed at four years after surgery"}

Secondary endpoints

• {"endpoint_text":"-overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"-IDFS in each study arm separately","definition_or_measurement_approach":"IDFS defined as time from surgery to first of: ipsilateral invasive breast tumour recurrence, local/regional invasive breast cancer recurrence, distant recurrence, death from any cause including breast cancer, contralateral invasive breast cancer or second primary non-breast invasive cancer (as per primary endpoint definition)"}
• {"endpoint_text":"-time from surgery to whatever comes first a) distant recurrence, b) death attributable to any cause incl. breast cancer or c) second primary non-breast invasive cancer","definition_or_measurement_approach":"Time from surgery to first occurrence of distant recurrence, death from any cause including breast cancer, or second primary non-breast invasive cancer"}
• {"endpoint_text":"-Safety including incidence of adverse events","definition_or_measurement_approach":"Safety assessed by incidence of adverse events (no further measurement detail provided in record)"}

Germany

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

541

Number Of Sites

10

Number Of Participants

240

Primary sponsor

Full Name

Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Germany