A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
NCT ID: NCT03742102
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
243 participants
INTERVENTIONAL
2018-12-21
2027-02-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Arm 1
durvalumab + paclitaxel
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Paclitaxel
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Arm 2
durvalumab + paclitaxel + capivasertib
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Capivasertib
Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
Paclitaxel
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Arm 5
durvalumab + paclitaxel + oleclumab
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Oleclumab
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
Paclitaxel
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Arm 6
durvalumab + trastuzumab deruxtecan
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Trastuzumab deruxtecan
Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
Arm 7
durvalumab + datopotamab deruxtecan
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Datopotamab deruxtecan
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
Arm 8
durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)
Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Datopotamab deruxtecan
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
Interventions
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Durvalumab
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Capivasertib
Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
Oleclumab
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
Paclitaxel
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Trastuzumab deruxtecan
Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
Datopotamab deruxtecan
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Schmid, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Barts Cancer Institute
Locations
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Research Site
Tucson, Arizona, United States
Research Site
Columbia, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Dallas, Texas, United States
Research Site
Williamsburg, Virginia, United States
Research Site
Kelowna, British Columbia, Canada
Research Site
London, Ontario, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Opole, , Poland
Research Site
Rzeszów, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Cambridge, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Oxford, , United Kingdom
Countries
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Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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2018-000764-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933LC00001
Identifier Type: -
Identifier Source: org_study_id
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