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Clinical Trial Finder

Search Results

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Study Purpose

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Patients must be at least 18 years of age.
  • - Pathologically documented breast cancer that: 1.
Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic. 2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting. 3. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting.
  • - Patient must have adequate tumor sample from the metastatic setting for biomarker assessment.
  • - ECOG Performance Status of 0 or 1.
  • - Part 1.
1. Disease progression on or after the last systemic therapy prior to starting study treatment. 2. At least 1 prior treatment line in metastatic setting required.
  • - Part 2 (Modules 0 - 5) a) No prior lines of therapy for advanced/MBC allowed.
  • - Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed.
CNS Inclusion.
  • - Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
  • - Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy.
Key

Exclusion Criteria:

  • - Uncontrolled or significant cardiovascular disease.
  • - Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • - Lung-specific intercurrent clinically significant illnesses.
  • - Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • - Spinal cord compression or a history of leptomeningeal carcinomatosis.
  • - Prior treatment with immune checkpoint inhibitors.
  • - Prior treatment with an ADC containing a topoisomerase I inhibitor.
  • - Prior treatment with tucatinib.
CNS Exclusion.
  • - Modules 0 - 5: Has untreated brain metastasis.
- Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04538742
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Active, not recruiting
Countries Australia, Brazil, Canada, France, Germany, India, Italy, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Breast Cancer
Study Website: View Trial Website
Additional Details

This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2. The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.

Arms & Interventions

Arms

Experimental: Module 1- T-DXd and Durvalumab

T-DXd and Durvalumab

Experimental: Module 2- T-DXd and Pertuzumab

T-DXd and Pertuzumab

Experimental: Module 3- T-DXd and Paclitaxel

T-DXd and Paclitaxel (Arm not initiated in Part 2)

Experimental: Module 4- T-DXd and Durvalumab and Paclitaxel

T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)

Experimental: Module 0- T-DXd

T-DXd

Experimental: Module 5 - T-DXd and Tucatanib

T-DXd and tucatinib (Arm not initiated in Part 2)

Experimental: Module 6 - T-DXd and Tucatinib

T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)

Experimental: Module 7 - T-DXd

T-DXd monotherapy in patients with active brain metastases (Part 2 Only)

Interventions

Drug: - Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Drug: - Durvalumab

Durvalumab: administered as an IV infusion

Drug: - Paclitaxel

Paclitaxel: administered as an IV infusion

Drug: - Pertuzumab

Pertuzumab: administered as an IV infusion

Drug: - Tucatinib

Tucatinib administered orally (tablet) twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Fort Myers 4155995, Florida 4155751

Status

Address

Research Site

Fort Myers 4155995, Florida 4155751, 33901

Research Site, St. Petersburg 4171563, Florida 4155751

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Address

Research Site

St. Petersburg 4171563, Florida 4155751, 33705

Research Site, Commack 5113412, New York 5128638

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Address

Research Site

Commack 5113412, New York 5128638, 11725

Research Site, Harrison 5120095, New York 5128638

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Address

Research Site

Harrison 5120095, New York 5128638, 10604

Research Site, New York 5128581, New York 5128638

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Address

Research Site

New York 5128581, New York 5128638, 10016

Research Site, New York 5128581, New York 5128638

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Address

Research Site

New York 5128581, New York 5128638, 10065

Research Site, Columbus 4509177, Ohio 5165418

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Address

Research Site

Columbus 4509177, Ohio 5165418, 43219

Research Site, Nashville 4644585, Tennessee 4662168

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Address

Research Site

Nashville 4644585, Tennessee 4662168, 37203

Research Site, Fort Worth 4691930, Texas 4736286

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Address

Research Site

Fort Worth 4691930, Texas 4736286, 76104

Research Site, Fairfax 4758023, Virginia 6254928

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Address

Research Site

Fairfax 4758023, Virginia 6254928, 22031

International Sites

Research Site, Melbourne 2158177, Australia

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Address

Research Site

Melbourne 2158177, , 3000

Research Site, Barretos 3470451, Brazil

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Address

Research Site

Barretos 3470451, , 14784-400

Research Site, Belo Horizonte 3470127, Brazil

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Address

Research Site

Belo Horizonte 3470127, , 30150-274

Research Site, Natal 3394023, Brazil

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Address

Research Site

Natal 3394023, , 59075-740

Research Site, Porto Alegre 3452925, Brazil

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Address

Research Site

Porto Alegre 3452925, , 90610-000

Research Site, Porto Alegre 3452925, Brazil

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Address

Research Site

Porto Alegre 3452925, , 91350-200

Research Site, Rio de Janeiro 3451190, Brazil

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Address

Research Site

Rio de Janeiro 3451190, , 20560-120

Research Site, São Paulo 3448439, Brazil

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Address

Research Site

São Paulo 3448439, , 01317-001

Research Site, São Paulo 3448439, Brazil

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Address

Research Site

São Paulo 3448439, , 04029-000

Research Site, Sorocaba 3447399, Brazil

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Address

Research Site

Sorocaba 3447399, , 18030-005

Research Site, Montreal 6077243, Quebec 6115047, Canada

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Address

Research Site

Montreal 6077243, Quebec 6115047, H2X 0A9

Research Site, Québec 6325494, Quebec 6115047, Canada

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Address

Research Site

Québec 6325494, Quebec 6115047, G1S 4L8

Research Site, Toronto 6167865, Canada

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Address

Research Site

Toronto 6167865, , M5G 2M9

Research Site, Villejuif 2968705, France

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Address

Research Site

Villejuif 2968705, , 94805

Research Site, München 2867711, Germany

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Address

Research Site

München 2867711, , 81675

Research Site, Würzburg 2805615, Germany

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Address

Research Site

Würzburg 2805615, , 97080

Research Site, Delhi 1273294, India

Status

Address

Research Site

Delhi 1273294, , 110085

Research Site, Gurgaon 10547511, India

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Address

Research Site

Gurgaon 10547511, , 122001

Research Site, Madurai 1264521, India

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Address

Research Site

Madurai 1264521, , 625107

Research Site, Mumbai 1275339, India

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Address

Research Site

Mumbai 1275339, , 400012

Research Site, Bologna 3181928, Italy

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Address

Research Site

Bologna 3181928, , 40138

Research Site, Milan 3173435, Italy

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Address

Research Site

Milan 3173435, , 20141

Research Site, Napoli 9031661, Italy

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Address

Research Site

Napoli 9031661, , 80131

Research Site, Rome 3169070, Italy

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Address

Research Site

Rome 3169070, , 168

Research Site, Bydgoszcz 3102014, Poland

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Address

Research Site

Bydgoszcz 3102014, , 85-796

Research Site, Koszalin 3095049, Poland

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Address

Research Site

Koszalin 3095049, , 75-581

Research Site, Lodz 3093133, Poland

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Address

Research Site

Lodz 3093133, , 90-242

Research Site, Lublin 765876, Poland

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Address

Research Site

Lublin 765876, , 20-090

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 105229

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 109240

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 111123

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 115478

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 117997

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 121205

Research Site, Moscow 524901, Russia

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Address

Research Site

Moscow 524901, , 143423

Research Site, Saint Petersburg 498817, Russia

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Address

Research Site

Saint Petersburg 498817, , 195271

Research Site, Saint Petersburg 498817, Russia

Status

Address

Research Site

Saint Petersburg 498817, , 196603

Research Site, Saint Petersburg 498817, Russia

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Address

Research Site

Saint Petersburg 498817, , 197758

Research Site, Busan 1838524, South Korea

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Address

Research Site

Busan 1838524, , 602-739

Research Site, Seoul 1835848, South Korea

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Address

Research Site

Seoul 1835848, , 02841

Research Site, Seoul 1835848, South Korea

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Address

Research Site

Seoul 1835848, , 03080

Research Site, Seoul 1835848, South Korea

Status

Address

Research Site

Seoul 1835848, , 05505

Research Site, Seoul 1835848, South Korea

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Address

Research Site

Seoul 1835848, , 06351

Research Site, Barcelona 3128760, Spain

Status

Address

Research Site

Barcelona 3128760, , 08003

Research Site, L'Hospitalet de Llobregat 3120619, Spain

Status

Address

Research Site

L'Hospitalet de Llobregat 3120619, , 08908

Research Site, Madrid 3117735, Spain

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Address

Research Site

Madrid 3117735, , 28007

Research Site, Madrid 3117735, Spain

Status

Address

Research Site

Madrid 3117735, , 28050

Research Site, Seville 2510911, Spain

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Address

Research Site

Seville 2510911, , 41013

Research Site, Hualien City 1674504, Taiwan

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Address

Research Site

Hualien City 1674504, , 970

Research Site, Tainan City 1668355, Taiwan

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Research Site

Tainan City 1668355, , 704

Research Site, Taipei 1668341, Taiwan

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Address

Research Site

Taipei 1668341, , 10048

Research Site, Taipei 1668341, Taiwan

Status

Address

Research Site

Taipei 1668341, , 10449

Research Site, Taipei 1668341, Taiwan

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Address

Research Site

Taipei 1668341, , 11217

Research Site, Taipei 1668341, Taiwan

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Address

Research Site

Taipei 1668341, , 114

Research Site, Taipei 1668341, Taiwan

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Address

Research Site

Taipei 1668341, , 235

Research Site, Taoyuan 6696918, Taiwan

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Address

Research Site

Taoyuan 6696918, , 333

Research Site, Ankara 323786, Turkey (Türkiye)

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Address

Research Site

Ankara 323786, , 6100

Research Site, Edirne 747712, Turkey (Türkiye)

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Address

Research Site

Edirne 747712, , 22030

Research Site, Istanbul 745044, Turkey (Türkiye)

Status

Address

Research Site

Istanbul 745044, , 34662

Research Site, Istanbul 745044, Turkey (Türkiye)

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Address

Research Site

Istanbul 745044, , 34722

Research Site, Izmir 311046, Turkey (Türkiye)

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Address

Research Site

Izmir 311046, , 35100

Research Site, Buckhurst Hill 2654412, United Kingdom

Status

Address

Research Site

Buckhurst Hill 2654412, , IG9 5HX

Resources

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