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Triple Negative Breast NeoplasmsPhase 1/2BEGONIANCT03742102

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

A Phase 1/2 study testing Durvalumab, Capivasertib and Oleclumab in people with Triple Negative Breast Neoplasms, run by AstraZeneca at 32 sites in 6 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer Read more about this study

Who is it for?
Ages 18 to 130 years, women only
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
Durvalumab, Capivasertib and Oleclumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
32 sitesin 6 countries
Study dates
21 Dec 2018to 26 Feb 2027
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female
  • At least 18 years of age at the time of screening
  • Patient must have locally confirmed advanced/unresectable or metastatic TNBC.
  • No prior treatment for metastatic (Stage IV) TNBC
  • Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
  • WHO/ECOG status at 0 or 1 at enrollment
  • Patients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
  • Patients enrolled in Arm 8 (durvalumab + Dato-DXd) Must have PD-L1 positive tumor as determined by an IHC based assay

Who cannot join

  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
  • Untreated CNS metastases
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  • Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
Show all 19Show fewer
  • Female patients who are pregnant, breastfeeding
  • Cardiac Ejection Fraction less than 50%
  • Patients enrolled in Arm 2 only:
  • Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
  • Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
  • Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
  • Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months
  • Patients enrolled in Arm 7 and 8 only: Clinically significant corneal disease in the opinion of the Investigator.
  • Patients enrolled in Arm 6, 7 and 8 only:
  • History of or active interstitial lung disease/pneumonitis
  • Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (DS-1062a; Arm 7 and 8) treatment
  • Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy.

Trial locations and contacts

32 sites in 6 countries.

32 sites in 6 countries

United States8 sites

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Boston, Massachusetts, 02215

  • Research Site

    Columbia, Maryland, 21044

  • Research Site

    Dallas, Texas, 75246

  • Research Site

    Grand Rapids, Michigan, 49503

  • Research Site

    St Louis, Missouri, 63110

  • Research Site

    Tucson, Arizona, 85715

  • Research Site

    Williamsburg, Virginia, 23188

Other trials in United States

Poland7 sites

  • Research Site

    Gdansk, 80-952

  • Research Site

    Krakow, 31-501

  • Research Site

    Lublin, 20-090

  • Research Site

    Opole, 45-060

  • Research Site

    Rzeszów, 35-021

  • Research Site

    Warsaw, 02-781

  • Research Site

    Warsaw, 04-141

Other trials in Poland

Taiwan6 sites

  • Research Site

    Kaohsiung City, 80756

  • Research Site

    Taichung, 40447

  • Research Site

    Tainan, 70403

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 112

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Canada4 sites

  • Research Site

    Greenfield Park, Quebec, J4V 2H1

  • Research Site

    Kelowna, British Columbia, V1Y 5L3

  • Research Site

    London, Ontario, N6A 4L6

  • Research Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

United Kingdom4 sites

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    London, EC1M 6BQ

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Oxford, OX3 7LE

Other trials in United Kingdom

South Korea3 sites

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Read the detailed description

This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.

Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

Being tested
Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Trastuzumab deruxtecan
Keywords
Breast Cancer, TNBC, Triple Negative, Triple Negative Breast Cancer, Triple-Negative Breast Cancer, Triple-Negative Breast Neoplasm, ER-Negative PR-Negative HER2-Negative Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Neoplasms, PD-L1 high TNBC
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

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

  • DurvalumabDrug

    Also called MEDI4736

    Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8

  • CapivasertibDrug

    Also called AZD5363

    Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off

  • OleclumabDrug

    Also called MEDI9447

    Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1

  • PaclitaxelDrug

    Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off

  • Trastuzumab deruxtecanDrug

    Also called DS-8201a

    Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w

  • Datopotamab deruxtecanDrug

    Also called Dato-DXd; DS-1062a

    Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w

Study groups in NCT03742102
Study groupRoleWhat they receive
Arm 1Experimentaldurvalumab + paclitaxel
Receives: Drug: Durvalumab; Drug: Paclitaxel
Arm 2Experimentaldurvalumab + paclitaxel + capivasertib
Receives: Drug: Durvalumab; Drug: Capivasertib; Drug: Paclitaxel
Arm 5Experimentaldurvalumab + paclitaxel + oleclumab
Receives: Drug: Durvalumab; Drug: Oleclumab; Drug: Paclitaxel
Arm 6Experimentaldurvalumab + trastuzumab deruxtecan
Receives: Drug: Durvalumab; Drug: Trastuzumab deruxtecan
Arm 7Experimentaldurvalumab + datopotamab deruxtecan
Receives: Drug: Durvalumab; Drug: Datopotamab deruxtecan
Arm 8Experimentaldurvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)
Receives: Drug: Durvalumab; Drug: Datopotamab deruxtecan

What is being measured

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

  1. Dose Limiting Toxicity (DLT) Events

    The occurrence of a severe adverse event (meeting pre-specified criteria) that is at least possibly related to durvalumab and/or the novel oncology therapy in 6 DLT-evaluable patients

    Measured: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response). Confirmed response is defined as at least one visit response of CR or PR confirmed by a follow-up scan at least 4 weeks later showing CR or PR.

    Measured: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)

  2. Progression-free Survival (PFS)

    Time from date of first dose (at least one study intervention [durvalumab, paclitxel or novel oncology therapy]) until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)

    Measured: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)

  3. Duration of Response (DoR)

    Time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression (PD) or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). If a patient does not progress following a response, then their DoR will be censored at the last evaluable disease assessment date

    Measured: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)

  4. Overall Survival (Count)

    Number of patients with overall survival, the time from date of first dose (at least one study intervention [durvalumab, paclitxel or novel oncology therapy]) until the date of death by any cause

    Measured: From date of first dose until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)

  5. Overall Survival (Duration)

    Time from date of first dose (at least one study intervention [durvalumab, paclitxel or novel oncology therapy]) until the date of death by any cause

    Measured: From date of first dose of IP until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)

  6. Progression-free Survival at 6 Months (PFS6)

    Percentage of patients alive and progression-free at 6 months following date of first dose (at least one study intervention [durvalumab, paclitxel or novel oncology therapy])

    Measured: 6 months following date of first dose

Timeline

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

  1. First posted15 Nov 2018
  2. Study start21 Dec 2018
  3. Primary completion29 Nov 2024
  4. Study completion26 Feb 2027 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1: At least 20 patients in the durvalumab-paclitaxel arm and at least 30 patients in each of the other novel treatment combination arms will be enrolled, for a total of approximately 140 patients (durvalumab + paclitaxel arm and 4 novel treatment combination arms). Additional patients may be enrolled in order to have 20 or 30 evaluable (i.e. dosed) patients per durvalumab - paclitaxel arm or novel treatment combination arm, respectively. Part 2: Approximately 27 patients will be assigned to each treatment arm, for an anticipated total of 57 response-evaluable patients per arm (ie, 30 patients in Part 1 and 27 patients in Part 2 per treatment arm, with the exception of Arm 1, which will enroll 20 patients in Part 1 and will not be expanded to Part 2). Patient expansion from 30 patients in Part 1 to an additional 27 patients from Part 2 will be determined based on a futility analysis utilizing a Simon 2 Stage design.
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742102
Sponsor's protocol ID
D933LC00001
Other IDs
2018-000764-29, 2018
Acronym
BEGONIA
Status last verified
Aug 2026
First submitted
25 Oct 2018
Last updated
4 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Schmid P, Im SA, Nowecki Z, Wysocki PJ, Jassem J, Jung KH, Lord S, Armstrong J, Stewart R, Vukovic P, Denduluri N, Park YH. First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial. Nat Cancer. 2026 Jun;7(6):983-992. doi: 10.1038/s43018-026-01181-8. Epub 2026 Jun 8.

    PubMed 42259988

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab, Capivasertib and Oleclumab in people with Triple Negative Breast Neoplasms, run by AstraZeneca at 32 sites in 6 countries.

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 8 inclusion and 19 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Poland, Taiwan, Canada, United Kingdom and 1 more country. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose Limiting Toxicity (DLT) Events (time frame: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))). 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 NCT03742102, 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 4 Aug 2026.

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