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JOURNAL ONKOLOGIE – STUDIE
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An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

Rekrutierend

NCT-Nummer:
NCT05592483

Studienbeginn:
Juli 2023

Letztes Update:
18.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

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

Studienlocations
(3 von 124)

Research Site
36604 Mobile
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
32503 Pensacola
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60805 Evergreen Park
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60068 Park Ridge
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48075 Southfield
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
08103 Camden
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
11432 Jamaica
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
29605 Greenville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
37236 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
78229-3900 San Antonio
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
53215-3692 Milwaukee
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
29308-014 Cachoeiro de Itapemirim
BrazilRekrutierend» Google-Maps
Research Site
30130-100 Belo Horizonte
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
80040-170 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
08908 L'Hospitalet De Llobregat
SpainRekrutierend» Google-Maps
Research Site
35016 Las Palmas de Gran Canaria
SpainRekrutierend» Google-Maps
Research Site
38010 Sta. Cruz De Tenerife
SpainNoch nicht rekrutierend» Google-Maps
Research Site
11407 Jerez de la Frontera
SpainNoch nicht rekrutierend» Google-Maps
Research Site
CH-5405 Basel
SwitzerlandNoch nicht rekrutierend» Google-Maps
Research Site
HA6 2RN Rickmansworth
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
TA1 5DA Taunton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multi-center, observational prospective study that will characterize the

demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and

its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world

setting. This study is planned to be conducted in several countries and aims to enroll

approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast

cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in

the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6

months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable

and/or mBC who have received a prior chemotherapy in the metastatic setting or developed

disease recurrence during or within 6 months of completing adjuvant chemotherapy will be

enrolled into the study in North America only.

The planned duration of patient recruitment is approximately 18 months for HER2+ and

approximately 12 months for HER2 low.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients ≥18 years of age at time of consent.

- Histological or cytological confirmed diagnosis of unresectable and/or mBC.

- Documented HER2 status via a validated method.

- Adult patients with unresectable or metastatic HER2+ breast cancer who have received a

prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or

adjuvant setting and developed disease recurrence during or within 6 months of

completing therapy.

Or

Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast

cancer who have received a prior chemotherapy in the metastatic setting or developed

disease recurrence during or within 6 months of completing adjuvant chemotherapy.

- Decision to newly initiate monotherapy T-DXd per standard of care.

- Capable of providing informed consent and completing questionnaires.

Exclusion Criteria:

- Pregnancy or breastfeeding.

- History of other primary malignancies in 2 years prior to unresectable and/or mBC

diagnosis.

- Patients who at time of data collection for this study are participating in or have

participated in an interventional study that remains blinded.

Studien-Rationale

Primary outcome:

1. Real-World Time to Next Treatment (rwTTNT) (Time Frame - From first dose of T-DXd until study discontinuation (approximately 3 years)):
Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen.

2. T-Dxd treatment patterns for HER2+ cohort (Time Frame - Approximately 3 years):
Treatment patterns will be summarised using summary statistics.

Secondary outcome:

1. T-Dxd treatment patterns for HER2-low (Time Frame - Approximately 3 years):
Treatment patterns will be summarised using summary statistics.

2. Demographics and clinical charcteristics (Time Frame - At Baseline (14 to 30 days prior to T-DXd initiation)):
Summary statistics will be used to describe the Demographics and clinical characteristics

3. Number of patients with Physician reported Safety Events of Interest (SEIs) (Time Frame - From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)):
The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed.

4. Number of patients provided prophylactic and reactive treatment for SEIs management (Time Frame - From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)):
The management of SEIs will be characterized.

5. Real-World Time to Discontinuation (rwTTD) (Time Frame - From first dose of T-DXd until study discontinuation (approximately 3 years)):
Real-World Time to Discontinuation of T-DXd will be evaluated. rwTTD is defined as time from index date to the earliest date of T-DXd discontinuation, or death.

6. Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT) (Time Frame - Approximately 3 years):
Patient-reported tolerability will be evaluated by PGI-TT. Single question asking patients how bothered they were by the side effects of their cancer treatment, ranging from Not at all to Very much.

7. Symptomatic SEI as measured by selected items from National Cancer Institute Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) (Time Frame - Approximately 3 years):
Patient-reported tolerability will be evaluated by selected items from the NCI PRO-CTCAE. The following items are selected: nausea, vomiting, bloating of the abdomen, shortness of breath, cough, heart palpitations, hair loss, and fatigue, tiredness or lack of energy.

8. Daily Nausea and Vomiting symptom diary (Time Frame - From first dose of T-DXd until 3 months):
Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities.

Studien-Arme

  • HER2+ Cohort
    Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.
  • HER2-low cohort
    Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.

Geprüfte Regime

  • None (Observational Study) (Observational study):
    Not Applicable since observational study

Quelle: ClinicalTrials.gov


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