Breast CancerDB RESPONDNCT05592483

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

An observational study of Breast Cancer, run by AstraZeneca at 125 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Breast Cancer
What is being tested?: None (Observational Study)
How many people: 78 participants
Where: 125 sitesin 9 countries
Study dates: 7 Jul 2023to 29 May 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with HER2+ and HER2-low unresectable and/or mBC who are prescribed T-DXd for 2L or earlier metastatic treatment per standard of care.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

125 sites in 9 countries.

Country

City, postcode or hospital

125 sites in 9 countries

United States40 sites

Research Site
Annapolis, Maryland, 21401
Research Site
Atlanta, Georgia, 30318
Research Site
Boston, Massachusetts, 02111
Research Site
Camden, New Jersey, 08103
Research Site
Chandler, Arizona, 85224
Research Site
Dallas, Texas, 75230-6899
Research Site
Dallas, Texas, 75246
Research Site
El Paso, Texas, 79902
Research Site
Eugene, Oregon, 97401
Research Site
Everett, Washington, 98201
Research Site
Evergreen Park, Illinois, 60805
Research Site
Florham Park, New Jersey, 07932
Research Site
Fort Worth, Texas, 76104
Research Site
Germantown, Tennessee, 38138-1762
Research Site
Glenview, Illinois, 60026
Research Site
Greenville, South Carolina, 29605
Research Site
Jamaica, New York, 11432
Research Site
Kansas City, Missouri, 64111
Research Site
Knoxville, Tennessee, 37916
Research Site
Lake Success, New York, 11042
Research Site
Lexington, Kentucky, 40503
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90064
Research Site
Louisville, Kentucky, 40202
Research Site
McAllen, Texas, 78503
Research Site
McKinney, Texas, 75071
Research Site
Memphis, Tennessee, 38120
Research Site
Milwaukee, Wisconsin, 53215-3692
Research Site
Mobile, Alabama, 36604
Research Site
Nashville, Tennessee, 37236
Research Site
Park Ridge, Illinois, 60068
Research Site
Pensacola, Florida, 32503
Research Site
Portsmouth, Virginia, 23708
Research Site
Roanoke, Virginia, 24014
Research Site
Saint Paul, Minnesota, 55102-2389
Research Site
San Antonio, Texas, 78229-3900
Research Site
Santa Rosa, California, 95403
Research Site
Southfield, Michigan, 48075
Research Site
Tyler, Texas, 75702
Research Site
York, Pennsylvania, 17403

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Spain35 sites

Research Site
A Coruña, A Coruna, 15006
Research Site
Barakaldo, Vizcaya, 48903
Research Site
Barcelona, '8036
Research Site
Barcelona, 08003
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Burgos, 09006
Research Site
Cáceres, 10003
Research Site
Córdoba, 14004
Research Site
Donostia / San Sebastian, Guipuzcoa, 20014
Research Site
Elche, Alicante, 03203
Research Site
Jerez de la Frontera, Cadiz, 11407
Research Site
L'Hospitalet de Llobregat, Barcelona, 08908
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35016
Research Site
Lleida, 25198
Research Site
Logroño, La Rioja, 26006
Research Site
Madrid, Madrid, 28040
Research Site
Madrid, Madrid, 28046
Research Site
Madrid, 28041
Research Site
Majadahonda, Madrid, 28222
Research Site
Málaga, 29010
Research Site
Murcia, 30008
Research Site
Ourense, Galicia, 32005
Research Site
Oviedo, Principality of Asturias, 33011
Research Site
Palma de Mallorca, Balearic Islands, 07120
Research Site
Pamplona, Navarre, 31008
Research Site
Reus, Tarragona, 43204
Research Site
Santa Cruz de Tenerife, Canary Islands, 38010
Research Site
Santander, Cantabria, 39008
Research Site
Segovia, 40002
Research Site
Seville, 41009
Research Site
Toledo, 45004
Research Site
Valencia, 46014
Research Site
Zaragoza, Aragon, 50009
Research Site
Zaragoza, 50012

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Brazil10 sites

Research Site
Belo Horizonte, Minas Gerais, 30130-100
Research Site
Brasília, Federal District, 72115-700
Research Site
Cachoeiro de Itapemirim, Espírito Santo, 29308-014
Research Site
Curitiba, Paran, 80040-170
Research Site
Itajaí, 88301-220
Research Site
Porto Alegre, Rio Grande do Sul, 90619-900
Research Site
Porto Alegre, 90035-001
Research Site
Salvador, Estado de Bahia, 40170-110
Research Site
São Paulo, 01236030
Research Site
São Paulo, 06455-010

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Italy10 sites

Research Site
Brescia, 25123
Research Site
Brindisi, 72100
Research Site
Catania, 95126
Research Site
Cremona, 26100
Research Site
Palermo, 90127
Research Site
Pisa, 56126
Research Site
Roma, 00133
Research Site
Roma, 00144
Research Site
Torino, 10126
Research Site
Verona, 37126

Other trials in Italy

United Kingdom9 sites

Research Site
Coventry, CV2 2DX
Research Site
Huddersfield, HD3 3EA
Research Site
Inverness, Scotland, IV2 3BW
Research Site
Keighley, England, BD20 6TD
Research Site
Leeds, LS9 7TF
Research Site
Londonderry, Northern Ireland, BT47 6SB
Research Site
Manchester, M20 4BX
Research Site
Rickmansworth, England, HA6 2RN
Research Site
Taunton, Somerset, TA1 5DA

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Canada7 sites

Research Site
Calgary, Alberta, T2N 4N2
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Kitchener, Ontario, N2G 1G3
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Québec, G1S 4L8
Research Site
Surrey, British Columbia, V3V 1Z2
Research Site
Vancouver, British Columbia, VSZ 4E6

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Austria5 sites

Research Site
Graz, Styria, 8036
Research Site
Innsbruck, Tyrol, 6020
Research Site
Vienna, Nordrhein-Westfalen, 42781
Research Site
Vienna, 1010
Research Site
Wels, Upper Austria, A-4600

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Switzerland5 sites

Research Site
Basel, 4031
Research Site
Basel, CH-5405
Research Site
Bern, 3010
Research Site
Liestal, CH-4410
Research Site
Monthey, 1870

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Israel4 sites

Research Site
Beersheba, 8410101
Research Site
Haifa, 34362
Research Site
Jerusalem, Jerusalem, 91120
Research Site
Tel Aviv, Tel Aviv, 64239

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About this study

Official title: A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

Read the 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.

Conditions: Breast Cancer
Being tested: None (Observational Study)
Keywords: Real-World Evidence, Unresectable Breast Cancer, Metastatic Breast Cancer, HER2+, HER2-low, Observational, non-interventional
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

None (Observational Study)Other
Also called Observational study
Not Applicable since observational study

Study groups in NCT05592483
Study group	Role	What they receive
HER2+ Cohort		Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen. Receives: Other: None (Observational Study)
HER2-low cohort		Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy. Receives: Other: None (Observational Study)

What is being measured

The primary outcome is the main question the study is designed to answer.

Real-World Time to Next Treatment (rwTTNT)
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.
Measured: From first dose of T-DXd until study discontinuation (approximately 3 years)
T-Dxd treatment patterns for HER2+ cohort
Treatment patterns will be summarised using summary statistics.
Measured: Approximately 3 years

Secondary outcomes (8)

T-Dxd treatment patterns for HER2-low
Treatment patterns will be summarised using summary statistics.
Measured: Approximately 3 years
Demographics and clinical charcteristics
Summary statistics will be used to describe the Demographics and clinical characteristics
Measured: At Baseline (14 to 30 days prior to T-DXd initiation)
Number of patients with Physician reported Safety Events of Interest (SEIs)
The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed.
Measured: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
Number of patients provided prophylactic and reactive treatment for SEIs management
The management of SEIs will be characterized.
Measured: From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration)
Real-World Time to Discontinuation (rwTTD)
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.
Measured: From first dose of T-DXd until study discontinuation (approximately 3 years)
Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT)
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.
Measured: Approximately 3 years
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)
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.
Measured: Approximately 3 years
Daily Nausea and Vomiting symptom diary
Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities.
Measured: From first dose of T-DXd until 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202329 May 2024

First posted24 Oct 2022
Study start7 Jul 2023
Primary completion29 May 2024
Study completion29 May 2024

Why it stopped: The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05592483
Sponsor's protocol ID: D9673R00025
Acronym: DB RESPOND
Status last verified: Nov 2024
First submitted: 20 Oct 2022
Last updated: 7 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05592483
Acronym / sponsor ID: DB RESPOND / D9673R00025
Conditions: Breast Cancer
Keywords: Real-World Evidence, Unresectable Breast Cancer, Metastatic Breast Cancer, HER2+, HER2-low, Observational, non-interventional
Study type: Observational
Recruitment status: TerminatedReason stopped: The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.
Enrolment: 78 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Jul 2023 (actual)
Primary completion: 29 May 2024 (actual)
Study completion: 29 May 2024 (actual)
First posted: 24 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
HER2+ Cohort	–	Other: None (Observational Study)Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.
HER2-low cohort	–	Other: None (Observational Study)Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with HER2+ and HER2-low unresectable and/or mBC who are prescribed T-DXd for 2L or earlier metastatic treatment per standard of care.

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
None (Observational Study)Also: Observational studyNot Applicable since observational study	Other	HER2+ Cohort, HER2-low cohort

Primary outcome

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

8 secondary outcomes

T-Dxd treatment patterns for HER2-low
Time frame: Approximately 3 years
Demographics and clinical charcteristics
Time frame: At Baseline (14 to 30 days prior to T-DXd initiation)
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)
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)
Real-World Time to Discontinuation (rwTTD)
Time frame: From first dose of T-DXd until study discontinuation (approximately 3 years)
Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT)
Time frame: Approximately 3 years
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
Daily Nausea and Vomiting symptom diary
Time frame: From first dose of T-DXd until 3 months

Results and safety

The study was stopped early (reason given: The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
CSR not created for the study-rationaleLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

125 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by AstraZeneca at 125 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Spain, Brazil, Italy, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-World Time to Next Treatment (rwTTNT) (time frame: From first dose of T-DXd until study discontinuation (approximately 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.