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A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (DESTINY-B12)

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ClinicalTrials.gov Identifier: NCT04739761
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 20, 2021
First Posted Date  ICMJE February 5, 2021
Last Update Posted Date October 8, 2021
Actual Study Start Date  ICMJE June 22, 2021
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Objective Response Rate (ORR) in Participants without BM at Baseline (Cohort 1) [ Time Frame: From screening until progression of disease [PD] (Up to 2.5 Years) ]
    To describe the overall treatment effect of T- DXd in HER2-positive metastatic breast cancer (MBC) participants without baseline BM. An ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per RECIST 1.1.
  • Progression-free Survival (PFS) in Participants with BM at Baseline (Cohort 2) [ Time Frame: From screening until PD (Up to 2.5 Years) ]
    To describe the overall treatment effect of T- DXd in HER2-positive MBC participants with baseline BM. The PFS will be defined as the time from the date of the first dose of study intervention until the date of objective PD per RECIST 1.1 as assessed by ICR or death.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • Objective Response Rate (ORR) in Participants without BM at Baseline (Cohort 1) [ Time Frame: From screening until disease progression (Up to 2.5 Years) ]
    To describe the overall treatment effect of T- DXd in HER2+ metastatic breast cancer (MBC) participants without baseline BM. An ORR will be evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
  • Progression-free Survival in Participants with BM at Baseline (Cohort 2) [ Time Frame: From screening until disease progression (Up to 2.5 Years) ]
    To describe the overall treatment effect of T- DXd in HER2+ MBC participants with baseline BM. The PFS will be evaluated by RECIST 1.1.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Overall Survival (OS) in Months [ Time Frame: At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. An OS is defined as the time from the date of the first dose of study intervention until death due to any cause.
  • Duration of Response (DoR) [ Time Frame: Screening Day (-28 days) until end-of-treatment (EOT) (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. The DoR will be defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by ICR or death due to any cause.
  • Time to Progression [ Time Frame: Screening Day (-28 days) until PD (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. Time to progression by RECIST 1.1 per ICR is defined as the time from the date of the first dose of study intervention to the date of documented disease progression.
  • Duration of Treatment on Subsequent Lines of Therapy [ Time Frame: At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. Duration of treatment on subsequent therapy will be defined as the time from the date of first dose of a subsequent therapy until date of the last dose of that therapy.
  • Time to Second Progression or Death (PFS2) [ Time Frame: At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements. The PFS2 is defined as time from the first dose of study intervention to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death.
  • Incidence of new Symptomatic Central Nervous System (CNS) Metastasis During Treatment in Participants without BM at Baseline (Cohort 1) [ Time Frame: At Screening day (-28 days), Cycle 1 (15 days ± 2 days) Day 1 and Cycle 3 (15 days ± 2 days) Day 1 and thereafter every 3 subsequent cycles (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants without baseline BM using additional efficacy measurements.
  • Time to Next Progression (CNS or extracranial) or Death [ Time Frame: Screening Day (-28 days) until next PD (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression (central nervous system [CNS] progression) of BM in participants without baseline BM using additional efficacy measurements. The time to next progression is defined as the time from the date of the first documented isolated CNS progression to the date of the next documented disease progression (CNS or extracranial) per RECIST 1.1 or death, and will be summarized descriptively in participants who develop isolated CNS progression, receive local therapy, and continue on protocol therapy.
  • Site (CNS vs extracranial vs both) of Next Progression [ Time Frame: Screening Day (-28 days) until next PD (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression (CNS progression) of BM in participants without baseline BM using additional efficacy measurements. Site of next progression will be summarized descriptively in participants who develop isolated CNS progression, receive local therapy, continue on protocol therapy, and have a subsequent documented disease progression (CNS or extracranial) per RECIST 1.1.
  • Objective Response Rate in Participants with BM at Baseline (Cohort 2) [ Time Frame: From screening until PD (Up to 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. An ORR will be evaluated by RECIST 1.1 per ICR.
  • Central Nervous System Progression-free Survival in Participants with BM at Baseline (Cohort 2) [ Time Frame: At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. The CNS PFS is defined as time from the first dose of study intervention to CNS progression per CNS RECIST 1.1 or death resulting from any cause, whichever occurs first.
  • Time to new CNS Lesions in Participants with BM at Baseline (Cohort 2) [ Time Frame: Screening Day (-28 days) until EOT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. The time to new CNS lesions is defined as the time from the date of the first dose of study intervention to the date of documented new CNS lesions.
  • Central Nervous System Objective Response Rate in Participants with BM at Baseline by ICR (Cohort 2) [ Time Frame: Screening Day (-28 days) until EOT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. The CNS ORR is defined as the proportion of participants with measurable BM at baseline who have a confirmed CR or confirmed PR of brain lesions, as determined by ICR per CNS RECIST 1.1.
  • Central Nervous System Duration of Response in Participants with BM at Baseline (Cohort 2) [ Time Frame: Screening Day (-28 days) until EOT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. The CNS DoR will be defined as the time from the date of first documented confirmed CNS response until date of documented CNS progression per CNS RECIST 1.1 as assessed by ICR or death due to any cause.
  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter every 3 weeks (q3w) until 24 weeks post EOT visit and prior to second progression, and at the EOT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and health-related quality of life (HRQoL) in HER2+ MBC participants with or without baseline BM.
  • Neurologic Assessment in Neuro-Oncology Scale [ Time Frame: Cycle 1 (15 days ± 2 days [Day 1]), Cycle 2 (15 days ± 2 days) Day 1, Cycle 3 (15 days ± 2 days) Day 1, Cycle 4 (15 days ± 2 days) Day 1 thereafter subsequent Cycles until PD and at EOT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • Cognitive Functions Tests [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter q12w and at EOT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • MD Anderson Symptom Inventory Brain Tumor-specific Items [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter q3w until 24 weeks post EOT visit and prior to second progression, and at the EOT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • St. George's Respiratory Questionnaire - idiopathic pulmonary fibrosis version in Participants with Interstitial Lung Disease (ILD)/Pneumonitis [ Time Frame: After diagnosis of ILD/pneumonitis and thereafter once weekly until EOT and safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • Number of Participants with Adverse Events [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
  • Number of Participants with Investigator-assessed ILD/Pneumonitis or Rate of Investigator-assessed ILD/Pneumonitis [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until C4 (15 days ± 2 days) Day 1 and thereafter subsequent cycles until PD (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
  • Number of Participants with Adverse Events with BM at Baseline [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • Overall Survival [ Time Frame: At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements.
  • Duration of Treatment on Subsequent Lines of Therapy [ Time Frame: At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements.
  • Duration of Response [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements.
  • Time to Progression [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements.
  • Time to Second Progression or Death [ Time Frame: At safety F/U (40+7 days after last dose) visit, thereafter survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants with or without baseline BM using additional efficacy measurements.
  • Incidence of new Symptomatic Central Nervous System (CNS) Metastasis During Treatment in Participants without BM at Baseline (Cohort 1) [ Time Frame: At Screening day (-28 days), Cycle 1 (15 days ± 2 days) Day 1 and Cycle 3 (15 days ± 2 days) Day 1 and thereafter every 3 subsequent cycles (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression of BM in participants without baseline BM using additional efficacy measurements.
  • Time to Next Progression or Death [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression (CNS progression) of BM in participants with or without baseline BM using additional efficacy measurements.
  • Site of Next Progression [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe the treatment effect on the development and progression (CNS progression) of BM in participants with or without baseline BM using additional efficacy measurements.
  • Objective Response Rate in Participants with BM at Baseline (Cohort 2) [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. An ORR will be evaluated by RECIST 1.1.
  • Central Nervous System Progression-free Survival in Participants with BM at Baseline (Cohort 2) [ Time Frame: At safety follow-up (40+7 days after last dose) then survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM.
  • Time to new CNS Lesions in Participants with BM at Baseline (Cohort 2) [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM.
  • Objective Response Rate in Participants with BM at Baseline by Independent Central Review (Cohort 2) [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM. An ORR will be evaluated by RECIST 1.1 as determined by Independent Central Review.
  • Duration of Response in Brain in Participants with BM at Baseline (Cohort 2) [ Time Frame: Screening Day (-28 days) until EoT (Approximately 2.5 Years) ]
    To describe efficacy in participants with stable or untreated BM.
  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter every 3 weeks (q3w) until 24 weeks post EoT visit and prior to second progression, and at the EoT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and health-related quality of life (HRQoL) in HER2+ MBC participants with or without baseline BM.
  • Neurologic Assessment in Neuro-Oncology Scale [ Time Frame: Cycle 1 (15 days ± 2 days [Day 1, Day 8, and Day 15]), Cycle 2 (15 days ± 2 days) Day 1, Cycle 3 (15 days ± 2 days) Day 1, Cycle 4 (15 days ± 2 days) Day 1 thereafter subsequent Cycles until PD and at EoT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • Cognitive Functions Tests [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter q12w and at EoT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • MD Anderson Symptom Inventory Brain Tumor-specific Items [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, thereafter q3w until 24 weeks post EoT visit and prior to second progression, and at the EoT visit (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • St. George's Respiratory Questionnaire - idiopathic pulmonary fibrosis version in Participants with Interstitial Lung Disease (ILD)/Pneumonitis [ Time Frame: After diagnosis of ILD/pneumonitis and thereafter once weekly until EoT and safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline BM.
  • Number of Participants with Treatment-related Adverse Events [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
  • Number of Participants with Investigator-assessed ILD/Pneumonitis or Rate of Investigator-assessed ILD/Pneumonitis [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until C4 (15 days ± 2 days) Day 1 and thereafter subsequent cycles until PD (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
  • Number of Participants with Adverse Events with BM at Baseline [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1 until safety F/U (40+7 days after last dose) (Approximately 2.5 Years) ]
    To describe the safety profile of T-DXd.
  • Number of Participants with Positive Anti-drug Antibody titer for T-DXd [ Time Frame: Cycle 1 (15 days ± 2 days) Day 1, Cycle 2 (15 days ± 2 days) Day 1, Cycle 4 (15 days ± 2 days) Day 1 and thereafter every 4 cycles until survival F/U q3months ± 14 days (Approximately 2.5 Years) ]
    To investigate the immunogenicity of T-DXd.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Official Title  ICMJE An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)
Brief Summary This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Detailed Description

Approximately 500 eligible participants will be enrolled into 1 of 2 cohorts (250 participants in each cohort) according to the presence or absence of BMs at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline.

After study intervention discontinuation, all participants will undergo an end-of-treatment visit (within 7 days of discontinuation) and will be followed up for safety assessments 40 (+ up to 7) days after the discontinuation of all study intervention.

All participants will be followed up for survival status and duration of treatment on subsequent therapies after intervention discontinuation every 3 months (± 14 days) from the date of the safety follow-up until death, withdrawal of consent, or the end of the study, as per defined in the protocol.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Trastuzumab Deruxtecan
Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.
Other Name: fam-trastuzumab deruxtecan-nxki
Study Arms  ICMJE Experimental: Trastuzumab Deruxtecan
Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
Intervention: Drug: Trastuzumab Deruxtecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2021)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 19, 2024
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • Participants should have pathologically documented breast cancer that is: unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines
  • Participant must have either: no evidence of BM, or untreated BM on screening contrast brain magnetic resonance imaging/ computed tomography (MRI/CT) scan, not needing immediate local therapy or previously-treated stable or progressing BM
  • Participants with BMs must be neurologically stable
  • For participants requiring radiotherapy due to BMs, there should be an adequate washout period before day of first dosing:
  • ≥ 7 days since stereotactic radiosurgery or gamma knife
  • ≥ 21 days since whole brain radiotherapy
  • Eastern Cooperative Oncology Group performance status 0-1
  • Previous breast cancer treatment: radiologic or objective evidence of disease progression on trastuzumab, pertuzumab, or trastuzumab emtansine and no more than 2 lines/regimens of therapy in the metastatic setting
  • Participant with the following measurable: at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI and is suitable for accurate repeated measurements; or following Non-measurable diseases: Non-measurable, bone-only disease that can be assessed by CT or MRI or X-Ray. Lytic or mixed lytic bone lesions that can be assessed by CT or MRI or X-ray in the absence of measurable disease as defined above is acceptable; Participants with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible; and Non-measurable CNS disease (Cohort 2 only)
  • Adequate organ and bone marrow function within 14 days before the day of first dosing as defined in the protocol
  • left ventricular ejection fraction ≥ 50% within 28 days before enrollment
  • Negative pregnancy test (serum) for women of childbearing potential

Exclusion Criteria

  • Known or suspected leptomeningeal disease
  • Prior exposure to tucatinib treatment
  • Refractory nausea and vomiting, chronic gastrointestinal disease, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of T-DXd
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
  • Persistent toxicities (Common Terminology Criteria for Adverse Events Grade >1) caused by previous anticancer therapy, excluding alopecia
  • Based on screening contrast brain MRI/CT scan, participants must not have any of the following: any untreated brain lesions > 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of BMs; any brain lesion thought to require immediate local therapy; have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs not withstanding CNS-directed therapy
  • Has spinal cord compression
  • Known active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Participants with past or resolved hepatitis B virus infection are eligible, if negative for hepatitis B surface antigen and positive for anti-hepatitis B core antigen
  • Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd
  • Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (New York Heart Association Class II to IV)
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue or inflammatory disorders
  • Prior exposure, without adequate treatment washout period before the day of first dosing, to chloroquine/hydroxychloroquine: < 14 days
  • Anticancer chemotherapy: immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy: < 3 weeks
  • < 6 weeks for nitrosoureas or mitomycin
  • < 1 week for tyrosine kinase inhibitor (TKIs) approved for the treatment of non-small cell lung cancer - baseline CT scan must be completed after discontinuation of TKI
  • Antibody-based anticancer therapy: < 4 weeks
  • Any concurrent anticancer treatment. Concurrent use of hormonal therapy for noncancer- related conditions is allowed
  • Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation, radiation to the chest, or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
  • Participants with prior exposure to immunosuppressive medication within 14 days prior to first study dose
  • Participants with a known hypersensitivity to study intervention or any of the excipients of the product or other monoclonal antibodies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   Finland,   Germany,   Ireland,   Italy,   Japan,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04739761
Other Study ID Numbers  ICMJE D9673C00007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE
Principal Investigator: Nadia Harbeck, MD, PhD Head, Breast Center, Ludwig-Maximilians-University of Munich Department of Obstetrics and Gynecology Marchioninistr. 15, 81377 Munich, Germany
Principal Investigator: Nancy U. Lin, MD Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers Director, Metastatic Breast Cancer Program, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215
PRS Account AstraZeneca
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP