Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC (NCT05498896) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC
United Kingdom146 participantsStarted 2018-12-19
Plain-language summary
International, randomised, open label, neo-adjuvant phase II trial in women with newly diagnosed, non-metastatic, high-risk (node positive and/or tumour size ≥ 2cm), triple negative breast cancer. The study aims to evaluate the effects of adding ipatasertib to chemotherapy and atezolizumab in patients with and without PI3CA/AKT1/PTEN genetic alterations.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Willing and able to provide written informed consent prior to study entry
✓. Female ≥ 18 years of age
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
✓. Histologically confirmed TNBC
✓. Node-positive (cT1-4 cN1-2 M0) and/or tumour size ≥2 cm (cT2-T4 cN0-2 M0) with no prior treatment
✓. Adequate haematologic and end-organ function .
✓. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test. Patients must agree to use adequate contraception
✓. Ability to comply with the protocol
Exclusion criteria
✕. Evidence of metastatic breast cancer.
✕. Any systemic therapy (e.g. chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current breast cancer disease before study entry
✕. Prior exposure to any CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, anti-PD-1 or anti-PD-L1 antibody
✕. Concurrent bilateral invasive breast cancer
✕. Inflammatory breast cancer
What they're measuring
1
pCR
Timeframe: Time of definitive surgery (6 months after start of treatment)
. Active malignancy (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) within the past 36 months prior to study entry
✕. Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment
✕. Known intolerance to any of the study drugs (ie, paclitaxel, doxorubicin, epirubicin, cyclophosphamide) or any of their excipients