Breast CancerBREAKOUTNCT03078036
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
An observational study of Breast Cancer, run by AstraZeneca at 98 sites in 15 countries.
Trial summary
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Germline BRCA Test (blood), FoundationOne Dx Genomic Profile (archival Tumour Specimen) and Follow-up
- How many people
- 873 participants
- Where
- 98 sitesin 15 countries
- Study dates
- 13 Mar 2017to 20 May 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Centers for primary care of metastatic HER2-ve breast cancer patients
Who may be able to join
- Provision of signed, written and dated informed consent.
- Adult females (according to the age of majority/adulthood as defined by local regulations).
- Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease.
- Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal therapy) for metastatic breast cancer in the last 90 days and, at that time, are considered to have exhausted hormone therapy options (if HR+ve).
Who cannot join
- Previous enrolment in this study.
- Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site).
- Current participation in a clinical study with an investigational oncology product.
- Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy.
- Current commencement of PARPi treatment.
Trial locations and contacts
98 sites in 15 countries.
98 sites in 15 countries
United States14 sites
Research Site
Dallas, Texas, 75246
Research Site
Denton, Texas, 76210
Research Site
Denver, Colorado, 80218
Research Site
Flower Mound, Texas, 75028
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77024
Research Site
Houston, Texas, 77089
Research Site
Newport News, Virginia, 23601
Research Site
Paris, Texas, 75460
Research Site
San Antonio, Texas, 78217
Research Site
Santa Barbara, California, 93105
Research Site
The Woodlands, Texas, 77380
Research Site
Vancouver, Washington, 98684
Research Site
Wenatchee, Washington, 98801
United Kingdom13 sites
Research Site
Blackpool, Lancashire
Research Site
Derby, Derbyshire
Research Site
Exeter, Devon
Research Site
Huddersfield, West Yorkshire
Research Site
Huntingdon, Cambridgeshire
Research Site
Lancaster, Lancashire
Research Site
London, Greater London
Research Site
Peterborough, Cambridgeshire
Research Site
Stoke-on-Trent, Staffordshire
Research Site
Truro, Cornwall
Research Site
Warwick, Warwickshire
Research Site
Wolverhampton, West Midlands
Research Site
Worthing, East Sussex
Turkey (Türkiye)12 sites
Research Site
Adana
Research Site
Ankara
Research Site
Antalya
Research Site
Diyarbakır
Research Site
Istanbul
Research Site
Izmir
Research Site
Kocaeli
Research Site
Sakarya
Research Site
Samsun
Research Site
Tekirdağ
Research Site
Trabzon
Research Site
Van
Spain8 sites
Research Site
A Coruña, La Coruña
Research Site
Alcorcón, Madrid
Research Site
Barcelona
Research Site
Burgos
Research Site
Girona
Research Site
Huelva
Research Site
San Sebastián de los Reyes, Madrid
Research Site
Terrassa, Barcelona
Japan7 sites
Research Site
Chūōku, Tokyo-To
Research Site
Fukuoka, Fukuoka
Research Site
Kamogawa-shi, Chiba
Research Site
Matsuyama, Ehime
Research Site
Osaka, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Poland7 sites
Research Site
Brzozów
Research Site
Opole
Research Site
Wałbrzych
Research Site
Warsaw
Research Site
Wieliszew
Research Site
Wroclaw
Research Site
Żory
Russia7 sites
Research Site
Chelyabinsk
Research Site
Krasnodar
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Pyatigorsk
Research Site
Ryazan
Research Site
Tomsk
Italy5 sites
Research Site
Carpi, Modena
Research Site
Castellanza, Varese
Research Site
Milan
Research Site
Pavia
Research Site
Reggio Emilia
South Korea5 sites
Research Site
Busan
Research Site
Goyang-si, Gyeonggi-do
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Ulsan
Taiwan5 sites
Research Site
Changhua
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Canada4 sites
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
Kingston, Ontario, K7L 5P9
Research Site
Kitchener, Ontario, N2G 1G3
Research Site
Québec, G1S 4L8
Hungary4 sites
Research Site
Budapest
Research Site
Szeged
Research Site
Szekszárd
Research Site
Szolnok
Australia3 sites
Research Site
Ballarat, Victoria
Research Site
Kurralta Park, South Australia
Research Site
Redcliffe, Queensland
About this study
Official title: BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.
Read the detailed description
Background/Rationale: Within the setting of metastatic human epidermal growth factor receptor 2 negative (HER2-ve) breast cancer limited epidemiological data exist on the prevalence of pathogenic mutations of breast cancer susceptibility gene (BRCA) and other homologous recombination repair (HRR) genes. There are also limited data on the treatments and clinical outcomes of patients with such germline and somatic genetic profiles, particularly within this setting. This epidemiologic study will estimate the prevalence of germline breast susceptibility gene (gBRCA) mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy and, at that time, are considered to have exhausted hormone therapy options (if hormone receptor positive [HR+ve]), per investigator's opinion. Among those patients with a gBRCA gene mutation, treatment patterns and clinical outcomes will be described. This study may also explore the prevalence of somatic BRCA (sBRCA) mutations and other HRR gene mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy. The treatment patterns and clinical outcomes may be described among those patients with a sBRCA gene mutation and those with other HRR gene mutations.
- Conditions
- Breast Cancer
- Being tested
- Germline BRCA Test (blood), FoundationOne Dx Genomic Profile (archival Tumour Specimen), Follow-up
- Keywords
- HER2-ve metastatic breast cancer, gBRCA, sBRCA and HRR gene mutations
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Germline BRCA Test (blood)Genetic
If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.)
FoundationOne Dx Genomic Profile (archival Tumour Specimen)Genetic
Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows:
- Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies.
- Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile.
Follow-upOther
Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months.
- Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Human epidermal growth factor receptor 2 negative metastic breast cancer patients who have started 1st line systemic cytotoxic chemotheraphy and are considered to have exhausted hormone therapy options (if HR+ve), per investigator's opinion. Receives: Genetic: Germline BRCA Test (blood); Genetic: FoundationOne Dx Genomic Profile (archival Tumour Specimen); Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
The prevalence of gBRCA gene mutations will be evaluated by calculating the proportion of patients that test positive for a gBRCA gene mutation (BRCA1 mutated and/or BRCA2 mutated).
Measured: At one time point at inclusion in the study up to 12 months after the beginning of the study.
Secondary outcomes (3)
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Treatment patterns will be described by line of therapy. Treatment combinations, number of cycles per line, schedules, durations, and reason for discontinuation will be summarized descriptively.
Measured: 2.5 years (30 months) since the beginning of the study.
Progression free survival by line of therapy
Progression free survival (in months) for each line of treatment, defined as the time from the date of start of each line of treatment to the documented date of progression as determined by the investigator (radiologic or symptomatic), or death from any cause in the absence of progression.
Measured: 2.5 years (30 months) since the beginning of the study.
Overall survival by line of therapy
Overall survival (OS) defined as the time from the start date of first line chemotherapy in the metastatic setting until the date of death due to any cause, assessed up to 30 months. In addition, OS since diagnosis of metastatic breast cancer and OS since the start of each subsequent therapy will be estimated.
Measured: 2.5 years (30 months) since the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start13 Mar 2017
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles; University of Tubingen - Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078036
- Sponsor's protocol ID
- D0816R00012
- Acronym
- BREAKOUT
- Status last verified
- May 2020
- First submitted
- 10 Feb 2017
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koh SJ, Ohsumi S, Takahashi M, Fukuma E, Jung KH, Ishida T, Dai MS, Chang CH, Dalvi T, Walker G, Bennett J, O'Shaughnessy J, Balmana J. Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study. Breast Cancer. 2022 Jan;29(1):92-102. doi: 10.1007/s12282-021-01283-4. Epub 2021 Aug 31.
PubMed 34467476O'Shaughnessy J, Brezden-Masley C, Cazzaniga M, Dalvi T, Walker G, Bennett J, Ohsumi S. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res. 2020 Oct 27;22(1):114. doi: 10.1186/s13058-020-01349-9.
PubMed 33109210
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
- ClinicalTrials.gov ID
- NCT03078036
- Acronym / sponsor ID
- BREAKOUT / D0816R00012
- Conditions
- Breast Cancer
- Keywords
- HER2-ve metastatic breast cancer, gBRCA, sBRCA and HRR gene mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles; University of Tubingen - Germany
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 13 Mar 2017 (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.
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.
Detailed description
Background/Rationale: Within the setting of metastatic human epidermal growth factor receptor 2 negative (HER2-ve) breast cancer limited epidemiological data exist on the prevalence of pathogenic mutations of breast cancer susceptibility gene (BRCA) and other homologous recombination repair (HRR) genes. There are also limited data on the treatments and clinical outcomes of patients with such germline and somatic genetic profiles, particularly within this setting. This epidemiologic study will estimate the prevalence of germline breast susceptibility gene (gBRCA) mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy and, at that time, are considered to have exhausted hormone therapy options (if hormone receptor positive [HR+ve]), per investigator's opinion. Among those patients with a gBRCA gene mutation, treatment patterns and clinical outcomes will be described. This study may also explore the prevalence of somatic BRCA (sBRCA) mutations and other HRR gene mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy. The treatment patterns and clinical outcomes may be described among those patients with a sBRCA gene mutation and those with other HRR gene mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Genetic: Germline BRCA Test (blood), Genetic: FoundationOne Dx Genomic Profile (archival Tumour Specimen), Other: Follow-upHuman epidermal growth factor receptor 2 negative metastic breast cancer patients who have started 1st line systemic cytotoxic chemotheraphy and are considered to have exhausted hormone therapy options (if HR+ve), per investigator's opinion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Centers for primary care of metastatic HER2-ve breast cancer patients
Key inclusion criteria (4 listed)
- Provision of signed, written and dated informed consent.
- Adult females (according to the age of majority/adulthood as defined by local regulations).
- Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease.
- Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal therapy) for metastatic breast cancer in the last 90 days and, at that time, are considered to have exhausted hormone therapy options (if HR+ve).
Key exclusion criteria (5 listed)
- Previous enrolment in this study.
- Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site).
- Current participation in a clinical study with an investigational oncology product.
- Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy.
- Current commencement of PARPi treatment.
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 |
|---|---|---|
| Germline BRCA Test (blood)If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.) | Genetic | Observation |
| FoundationOne Dx Genomic Profile (archival Tumour Specimen)Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows: * Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies. * Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile. | Genetic | Observation |
| Follow-upPatients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months. - Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study. | Other | Observation |
Primary outcome
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Time frame: At one time point at inclusion in the study up to 12 months after the beginning of the study.
The prevalence of gBRCA gene mutations will be evaluated by calculating the proportion of patients that test positive for a gBRCA gene mutation (BRCA1 mutated and/or BRCA2 mutated).
3 secondary outcomes
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Time frame: 2.5 years (30 months) since the beginning of the study.
Progression free survival by line of therapy
Time frame: 2.5 years (30 months) since the beginning of the study.
Overall survival by line of therapy
Time frame: 2.5 years (30 months) since the beginning of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 34467476Koh SJ, Ohsumi S, Takahashi M, Fukuma E, Jung KH, Ishida T, Dai MS, Chang CH, Dalvi T, Walker G, Bennett J, O'Shaughnessy J, Balmana J. Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study. Breast Cancer. 2022 Jan;29(1):92-102. doi: 10.1007/s12282-021-01283-4. Epub 2021 Aug 31.
- Derived from this study: PubMed 33109210O'Shaughnessy J, Brezden-Masley C, Cazzaniga M, Dalvi T, Walker G, Bennett J, Ohsumi S. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res. 2020 Oct 27;22(1):114. doi: 10.1186/s13058-020-01349-9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
98 sites in 15 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 98 sites in 15 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, United Kingdom, Turkey (Türkiye), Spain, Japan and 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type). (time frame: At one time point at inclusion in the study up to 12 months after the beginning of the study.). 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 NCT03078036, which also lists 2 linked publications.
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 20 May 2020.