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Triple Negative Breast CancerPhase 2BARBICANNCT05498896

Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC

A Phase 2 study testing Atezolizumab, Ipatasertib and Paclitaxel in people with Triple Negative Breast Cancer, run by Queen Mary University of London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Atezolizumab, Ipatasertib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited Kingdom
Study dates
19 Dec 2018to 31 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .
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  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Barts Health NHS Trust

    London

Other trials in United Kingdom

About this study

Official title: 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

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.

Keywords
PI3CA/AKT1/PTEN genetic alterations, Newly diagnosed TNBC, Ipatasertib, Atezolizumab, Neo-adjuvant
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05498896
Study groupRoleWhat they receive
Atezolizumab + ChemotherapyOtherAtezolizumab (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)
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide
Atezolizumab + Chemotherapy + IpatasertibExperimentalAtezolizumab (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).
Receives: Drug: Atezolizumab; Drug: Ipatasertib; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR

    pCR defined as no microscopic evidence of residual invasive tumour

    Measured: Time of definitive surgery (6 months after start of treatment)

Secondary outcomes (1)

  1. ORR

    ORR as assessed by RECIST 1.1 principles, defined as percentage of subjects with best overall response of complete response (CR) or partial response (PR) in the relevant analysis population.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start19 Dec 2018
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498896
Sponsor's protocol ID
012418QM
Other IDs
2018-000977-62, 2018
Acronym
BARBICAN
Status last verified
May 2026
First submitted
24 Feb 2020
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Ipatasertib and Paclitaxel in people with Triple Negative Breast Cancer, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: Time of definitive surgery (6 months after start of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05498896, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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