Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC
BARBICAN
A Randomised, Open-label Phase II Study to Determine the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in Women With Triple-negative Breast Cancer
2 other identifiers
interventional
146
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2018
CompletedFirst Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 8, 2026
May 1, 2026
7.7 years
February 24, 2020
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pCR
pCR defined as no microscopic evidence of residual invasive tumour
Time of definitive surgery (6 months after start of treatment)
Secondary Outcomes (1)
ORR
5 years
Study Arms (2)
Atezolizumab + Chemotherapy
OTHERAtezolizumab (1200mg IV Q3W x 1 cycle) followed by Paclitaxel (80 mg/m2 Q1W x 12) plus Atezolizumab 840 mg (Q2W x 6) followed by Doxorubicin (60 mg/m2) plus Cyclophosphamide (600 mg/m2 Q2W x 4) plus Atezolizumab (840 mg Q2W x 4)
Atezolizumab + Chemotherapy + Ipatasertib
EXPERIMENTALAtezolizumab (1200 mg, Q3W x 1 cycle), plus Ipatasertib (400 mg OD, days 1-14) followed by Paclitaxel (80 mg/m2 Q1W x 12) plus Atezolizumab (840 mg Q2W x 6), plus Ipatasertib, (400 mg OD, days 1-21 Q4W) followed by Doxorubicin (60 mg/m2) plus Cyclophosphamide (600 mg/m2 Q2W x 4) plus Atezolizumab (840 mg Q2W x 4).
Interventions
IV infusion
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- Pre-existing peripheral neuropathy grade ≥ 2
- History of autoimmune disease
- 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
- History of idiopathic pulmonary fibrosis or organising pneumonia
- History of HIV infection
- Known active hepatitis infection or hepatitis C.
- Active tuberculosis
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen Mary University of Londonlead
- Westdeutsche Studiengruppe GmbH (WSG)collaborator
- MedSIRcollaborator
- Hoffmann-La Rochecollaborator
Study Sites (1)
Barts Health NHS Trust
London, United Kingdom
Related Publications (1)
P. Schmid, F.J. Salvador Bofill, B. Bermejo, et al. BARBICAN: A randomized, phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer. Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Schmid
Queen Mary University of London
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
August 12, 2022
Study Start
December 19, 2018
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05