Brief description of trial (Data source: BASEC)
Eine multizentrische, randomisierte, offene, aktiv kontrollierte Phase-III-Studie zu DS-8201a im Vergleich zur Behandlung der Wahl des Arztes (2:1) bei Brustkrebspatienten/-innen mit nicht resezierbaren und/oder metastasierenden Tumoren mit niedriger HER2 Gen Vorkommen.
An der Studie werden voraussichtlich ungefähr 360 Personen, die DS-8201a erhalten, und ungefähr 180 Personen teilnehmen, die eine Behandlung erhalten, die von ihrem Arzt festgelegt wird.
• 60 Hormonrezeptor (HR)-negativ Patienten/-innen
• 240 Hormonrezeptor (HR)-positive Patienten/-innen, die zuvor mit Cyclin-abhängigen Kinasen (CDK) 4/6-Inhibitoren (Hemmstoffen) behandelt wurden.
• 240 HR-positive Patienten/-innen, die nicht mit CDK 4/6 behandelt wurden
Die Zuteilung erfolgt zufallsbedingt.
Es wird wahrscheinlich ungefähr 161 Studienzentren in Nordamerika, Westeuropa, Asien, aber auch in weiteren Ländern geben.
Es sind Nachuntersuchungstermine nach der endgültigen Beendigung der Studienbehandlung geplant, um Informationen über die nachfolgende(n) Behandlung(en) und die Überlebensrate zu erhalten.
Der Sponsor (Auftraggeber der Studie) schlägt vor, in dieser Studie eine neue Population mit niedrigem HER2- Gen-Vorkommen zu definieren.
Health conditions investigated(Data source: BASEC)
Brustkrebs mit niedriger HER2-Expression
Health conditions
(Data source: WHO)
Breast Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Experimentell: DS-8201a
DS-8201a wird alle 21 Tage zunächst für mindestens 90 Minuten intravenös (IV) verabreicht. Wenn keine infusionsbedingte Reaktion auftritt, wird die Verabreichung mindestens 30 Minuten dauern.
Wirksame Vergleichsbehandlung: Wahl des Arztes
Die vom Arzt gewählte Vergleichstherapie wird gemäss dem örtlich zugelassenen Beipackzettel verabreicht. Vor der Randomisierung sind die Wahlmöglichkeiten des Arztes auf die folgenden Optionen beschränkt:
• Capecitabin
• Eribulin
• Gemcitabin
• Paclitaxel
• Nab-Paclitaxel
Interventions
(Data source: WHO)
Drug: Trastuzumab deruxtecan (DS-8201a);Drug: Capecitabine;Drug: Eribulin;Drug: Gemcitabine;Drug: Paclitaxel;Drug: Nab-paclitaxel
Criteria for participation in trial
(Data source: BASEC)
• Volljährigkeit in dem jeweiligen Land
• Leidet an abnormal dokumentiertem Brustkrebs, der
1. inoperabel oder metastasierend ist
2. der eine niedrige HER2 Expression (bestimmtes Gen) hat
3. HR (hormonrezeptor)-positiv oder HR (hormonrezeptor)-negativ
• hat einen radiologisch bestätigten Krankheitsfortschritt (während oder nach der letzten Behandlung)
Exclusion criteria
(Data source: BASEC)
• ist für alle Optionen im Arztwahlarm ungeeignet
• hat Brustkrebs, der zu einem beliebigen Zeitpunkt eine hohe HER2 Expression gezeigt hat
• ist zuvor mit einer Anti-HER2 Therapie, einschliesslich Antikörper-Wirkstoff-Konjugat, behandelt worden
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Is the age of majority in their country
- Has pathologically documented breast cancer that:
1. Is unresectable or metastatic
2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
3. Is HR-positive or HR-negative
4. Has progressed on, and would no longer benefit from, endocrine therapy
5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the
recurrent or metastatic setting
6. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing
(per American Society of Clinical Oncology-College of American Pathologists
[ASCO-CAP] guidelines)
- Has documented radiologic progression (during or after most recent treatment)
- Has adequate archival tumor samples available or is wiling to provide fresh biopsies
prior to randomization for:
1. assessment of HER2 status
2. assessment of post-treatment status
- Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
- Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting
functions
- Male and female participants of reproductive/childbearing potential, agrees to follow
instructions for method(s) of contraception and agrees to avoid preserving ova or
sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion Criteria:
- Is ineligible for all options in the physician's choice arm
- Has breast cancer ever assessed with high-HER2 expression
- Has previously been treated with any anti-HER2 therapy, including an antibody drug
conjugate
- Has uncontrolled or significant cardiovascular disease
- Has spinal cord compression or clinically active central nervous system metastases
- Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that
cannot be ruled out by imaging at screening
- Has any medical history or condition that per protocol or in the opinion of the
investigator is inappropriate for the study
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cance
Secundary end point
(Data source: WHO)
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status;Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer;Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients);Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer;Number of Overall Survival Events (Deaths);Overall Survival (OS) in All Patients;Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer;Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients);Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer;Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Aarau, Basel, Chur, Lausanne, St. Gallen, Winterthur, Zurich
Countries
(Data source: WHO)
Austria, Belgium, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Portugal, Republic of, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Andreas Müller
+41 52 266 36 44
andreas.mueller@ksw.ch
Contact for general information
(Data source: WHO)
Global Clinical Leader
Daiichi Sankyo
Contact for scientific information
(Data source: WHO)
Global Clinical Leader
Daiichi Sankyo
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
04.12.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-00528
Secondary ID (Data source: WHO)
2018-003069-33
184223
DESTINY-B04
DS8201-A-U303
Back to overview