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Trial Title:
Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC
NCT ID:
NCT05498896
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Doxorubicin
Atezolizumab
Ipatasertib
Conditions: Keywords:
PI3CA/AKT1/PTEN genetic alterations
Newly diagnosed TNBC
Ipatasertib
Atezolizumab
Neo-adjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
IV infusion
Arm group label:
Atezolizumab + Chemotherapy
Arm group label:
Atezolizumab + Chemotherapy + Ipatasertib
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
Ipatasertib
Description:
Oral
Arm group label:
Atezolizumab + Chemotherapy + Ipatasertib
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV infusion
Arm group label:
Atezolizumab + Chemotherapy
Arm group label:
Atezolizumab + Chemotherapy + Ipatasertib
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
IV infusion
Arm group label:
Atezolizumab + Chemotherapy
Arm group label:
Atezolizumab + Chemotherapy + Ipatasertib
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
IV infusion
Arm group label:
Atezolizumab + Chemotherapy
Arm group label:
Atezolizumab + Chemotherapy + Ipatasertib
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willing and able to provide written informed consent prior to study entry
2. Female ≥ 18 years of age
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
4. Histologically confirmed TNBC
5. Node-positive (cT1-4 cN1-2 M0) and/or tumour size ≥2 cm (cT2-T4 cN0-2 M0) with no
prior treatment
6. Adequate haematologic and end-organ function .
7. Patients of childbearing potential are eligible provided they have a negative serum
or urine pregnancy test. Patients must agree to use adequate contraception
8. Ability to comply with the protocol
9. Representative formalin-fixed paraffin embedded breast tumour samples with an
associated pathology report, determined to be available and sufficient for central
testing OR tumour accessible for biopsy
Exclusion Criteria:
1. Evidence of metastatic breast cancer.
2. Any systemic therapy (e.g. chemotherapy, targeted therapy, immune-therapy) or
radiotherapy for current breast cancer disease before study entry
3. Prior exposure to any CD137 agonists or immune checkpoint blockade therapies,
including antiCTLA-4, anti-PD-1 or anti-PD-L1 antibody
4. Concurrent bilateral invasive breast cancer
5. Inflammatory breast cancer
6. 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
7. Major surgery within the last 28 days or anticipation of the need for major surgery
during study treatment
8. Known intolerance to any of the study drugs (ie, paclitaxel, doxorubicin,
epirubicin, cyclophosphamide) or any of their excipients
9. Pre-existing peripheral neuropathy grade ≥ 2
10. History of autoimmune disease
11. History of Type I or Type II diabetes mellitus requiring insulin. Patients who are
on a stable dose of oral diabetes medication ≥ 2 weeks prior to initiation of study
treatment are eligible for enrolment
12. History of idiopathic pulmonary fibrosis or organising pneumonia
13. History of HIV infection
14. Known active hepatitis infection or hepatitis C.
15. Active tuberculosis
19. Current treatment with anti-viral therapy for HBV
20. Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of
the drug (whichever is longer) prior to initiation of study treatment
21. Patients receiving concomitant immunosuppressive agents or chronic systemic
corticosteroids (≥10 mg prednisolone or an equivalent dose of other
anti-inflammatory corticosteroids) use for ≥28 days at the time of study entry.
22. Significant cardiovascular disease
16. Severe infection within 4 weeks prior to initiation of study treatment
23. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the investigator's opinion, gives reasonable suspicion
of a disease or condition that contraindicates the use of an investigational drug,
may affect the interpretation of the results, render the patient at high risk from
treatment complications or interferes with obtaining informed consent
24. Psychological, familial, sociological or geographical conditions that do not permit
compliance with the study protocol
25. Concurrent treatment with other experimental drugs. Participation in another
clinical trial with any investigational drug within 30 days prior to study entry
26. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5
drug-elimination half-lives, whichever is longer, prior to initiation of study drug
27. Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding
alopecia and peripheral neuropathy
28. Pregnant or nursing women
29. Inability to swallow medication or malabsorption condition that would alter the
absorption of orally administered medications
30. Clinically significant abnormalities of glucose metabolism
31. History of or active inflammatory bowel disease or active bowel inflammation
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Barts Health NHS Trust
Address:
City:
London
Country:
United Kingdom
Start date:
December 19, 2018
Completion date:
January 30, 2026
Lead sponsor:
Agency:
Queen Mary University of London
Agency class:
Other
Collaborator:
Agency:
Westdeutsche Studiengruppe GmbH (WSG)
Agency class:
Other
Collaborator:
Agency:
MedSIR
Agency class:
Other
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Queen Mary University of London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498896
