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New drug cocktail aims to tame aggressive breast cancer

NCT ID NCT03742102

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests whether combining the immunotherapy drug durvalumab with other cancer treatments (with or without chemotherapy) can help control metastatic triple negative breast cancer in people who have not had prior treatment for advanced disease. About 243 women with advanced or metastatic TNBC will receive different drug combinations to see how well they shrink tumors and what side effects occur. The goal is disease control, not a cure, as ongoing management is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

243 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Female 2. At least 18 years of age at the time of screening 3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC. 4. No prior treatment for metastatic (Stage IV) TNBC 5. Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured 6. 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 Exclusion criteria 1. History of allogeneic organ transplantation 2. Active or prior documented autoimmune or inflammatory disorders 3. 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) 4. Untreated CNS metastases 5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients 6. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment 7. Female patients who are pregnant, breastfeeding 8. Cardiac Ejection Fraction less than 50% Patients enrolled in Arm 2 only: 1. 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) 2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment. 3. 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 4. 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: 1. History of or active interstitial lung disease/pneumonitis 2. 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 3. Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy.

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast neoplasms

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85715, United States

  • Research Site

    Columbia, Maryland, 21044, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Williamsburg, Virginia, 23188, United States

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    London, Ontario, N6A 4L6, Canada

  • Research Site

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Krakow, 31-501, Poland

  • Research Site

    Lublin, 20-090, Poland

  • Research Site

    Opole, 45-060, Poland

  • Research Site

    Rzeszów, 35-021, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Warsaw, 04-141, Poland

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    London, EC1M 6BQ, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Oxford, OX3 7LE, United Kingdom

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Other studies related to the condition(s) this trial covers.