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JOURNAL ONKOLOGIE – STUDIE
DB-06

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Rekrutierend

NCT-Nummer:
NCT04494425

Studienbeginn:
Juli 2020

Letztes Update:
18.05.2021

Wirkstoff:
Trastuzumab Deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 287)

Research Site
10117 Berlin
(Berlin)
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01307 Dresden
(Sachsen)
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79110 Freiburg
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20246 Hamburg
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30625 Hannover
(Niedersachsen)
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04103 Leipzig
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80337 München
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81675 München
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48149 Münster
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72016 Tübingen
(Baden-Württemberg)
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42551 Velbert
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85259 Scottsdale
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55905 Rochester
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43210 Columbus
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15212 Pittsburgh
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77030 Houston
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77054 Houston
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77380 Spring
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98104 Seattle
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53792-5666 Madison
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C1125ABD Ciudad Autonoma De Buenos Aire
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1280 Ciudad de Buenos Aires
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7600 Mar del Plata
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4000 San Miguel de Tucumán
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4600 San Salvador de Jujuy
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2065 St Leonards
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14784-400 Barretos
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30110-022 Belo Horizonte
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60430-230 Fortaleza
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90610-000 Porto Alegre
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91350-200 Porto Alegre
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20560-120 Rio de Janeiro
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01317-000 Sao Paulo
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18030-510 Sorocaba
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04038-034 São Paulo
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J1H 5N4 Sherbrooke
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69495 Pierre Benite
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94805 Villejuif Cedex
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695011 Thiruvananthapuram
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811-1395 Fukuoka-shi
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791-0280 Matsuyama-shi
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663-8501 Nishinomiya-shi
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700-8558 Okayama-shi
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589-8511 Osakasayama-shi
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142-8666 Shinagawa-ku
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420-8527 Shizuoka-shi
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41404 Daegu
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410-769 Goyang-si
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13620 Seongnam-si
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06700 Alc. Cuauhtémoc
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44280 Guadalajara Jalisco
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'14080 Mexico City
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1066 CX Amsterdam
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7555 DL Hengelo
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8934 AD Leeuwarden
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6162 BG Sittard-Geleen
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163045 Arkhangelsk
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111123 Moscow
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115478 Moscow
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195271 Saint Petersburg
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197758 Saint Petersburg
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190103 Saint-Petersburg
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197758 Sankt-Peterburg
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21423 Jeddah
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12713 Riyadh
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119074 Singapore
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258499 Singapore
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308433 Singapore
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329563 Singapore
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20014 San Sebastián
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CF14 2TL Cardiff
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Studien-Informationen

Detailed Description:

Eligible patients will be those patients who have had disease progression on at least 2

previous lines of endocrine therapies given for the treatment of metastatic disease. All

patients must have historically confirmed HR positive (either estrogen receptor and/or

progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0

<1+ expression, as determined by central laboratory testing results, advanced or metastatic

breast cancer.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan

compared with investigator's choice chemotherapy. This study aims to see if trastuzumab

deruxtecan allows patients to live longer without the cancer getting worse, or simply to live

longer, compared to patients receiving standard of care chemotherapy. This study is also

looking to see how the treatment and the cancer affects patients' quality of life.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Patients must be ≥18 years of age

- Pathologically documented breast cancer that:

1. is advanced or metastatic

2. has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+

(ISH- or untested) or HER2 IHC 0 (ISH- or untested)

3. has HER2-low or HER2 IHC >0 <1+ expression

4. was never previously HER2-positive

5. is documented HR+ disease in the metastatic setting.

- No prior chemotherapy for advanced or metastatic breast cancer.

- Has adequate tumor samples for assessment of HER2 status

- Either disease progression on at least 2 previous lines of endocrine therapy with or

without a targeted therapy in the metastatic setting or disease progression within 24

months of starting adjuvant endocrine therapy and on at least 1 previous line of

endocrine therapy in the metastatic setting

- Has protocol-defined adequate organ and bone marrow function

Key Exclusion Criteria:

- Ineligible for all options in the investigator's choice chemotherapy arm

- Lung-specific intercurrent clinically significant illnesses

- Uncontrolled or significant cardiovascular disease or infection

- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected

ILD/pneumonitis that cannot be ruled out by imaging at screening

- Patients with spinal cord compression or clinically active central nervous system

metastases

- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless

of treatment arm assignment

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) - in HR+, HER2-low populaton (Time Frame - Until progression or death, assessed up to approximately 60 months):
Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.



Secondary outcome:

1. Overall Survival (OS) - in HR+, HER2-low population (Time Frame - Until death, assessed up to approximately 60 months):
Defined as the time from randomization to death due to any cause

2. Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) (Time Frame - Until progression or death, assessed up to approximately 60 months):
PFS by BICR according to RECIST 1.1 in ITT population

3. Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) (Time Frame - Until death, assessed up to approximately 60 months):
OS in the ITT population

4. Objective Response Rate (ORR) in HR+, HER-2 low populaton (Time Frame - Until progression, assessed up to approximately 60 months):
ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.

5. Duration of response (DoR) - in HR+, HER-2 low populaton (Time Frame - Until progression, assessed up to approximately 60 months):
DoR defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by BICR and Investigator assessment according to RECIST 1.1

6. Progression Free Survival by Investigator assessment - in the HR+, HER2-low population (Time Frame - Until progression or death, assessed up to approximately 60 months):
PFS using investigator assessments according to RECIST 1.1 in the HER2-low population

7. Objective Response Rate (ORR) in the ITT population (Time Frame - Until progression, assessed up to approximately 60 months):
ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

8. Duration of response (DoR) - in the ITT population (Time Frame - Until progression, assessed up to approximately 60 months):
DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

9. PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population (Time Frame - Assessed up to approximately 60 months):
PFS2 defined as time from randomisation to second progression or death. TFST defined as a time elapsed from randomization to first subsequent therapy or death. TSST defined as a time elapsed from randomization to second subsequent therapy or death.

10. Safety and tolerability of drugs; number of adverse events (AEs) (Time Frame - Up to follow-up period, approximately 60 months):
Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm

11. Serum concentration of trastuzumab deruxtecan (Time Frame - Up to Cycle 8, approximately Week 24; each cycle is 21 days):
Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration

12. Immunogenicity of trastuzumab deruxtecan (Time Frame - Up to follow-up period, approximately 60 months):
Percentage of patients who develop ADA for trastuzumab deruxtecan

13. Health-related quality of life - EORTC-QLQ-C30 (Time Frame - Assessed up to approximately 60 months):
Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

14. Time to deterioration in EORTC-QLQ-C30 scores (Time Frame - Assessed up to approximately 60 months):
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

15. Health-related quality of life - EORTC QLQ-BR45 (Time Frame - Assessed up to approximately 60 months):
Change from baseline in the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR45) score. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

Studien-Arme

  • Experimental: Trastuzumab deruxtecan
    Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
  • Active Comparator: Standard of Care
    Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Geprüfte Regime

  • Trastuzumab deruxtecan (DS-8201a; T-DXd):
    Trastuzumab deruxtecan by intravenous infusion
  • Capecitabine:
    Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
  • Paclitaxel:
    Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
  • Nab-Paclitaxel:
    Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Quelle: ClinicalTrials.gov


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