Breast NeoplasmsNCT05367739
Real World Study on the Efficacy and Safety of Anti-HER2 Therapy
An observational study of Breast Neoplasms and HER2-positive Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, HER2-positive Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jul 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2 positive breast cancer patients who plan to receive anti-HER2 therapy
Who may be able to join
- Age ≥ 18 years old, voluntary consent and signed written informed consent.
- ECOG 0~2.
- Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
- At least one measurable disease lesion before treatment.
- Anticipated survival time is longer than three months.
- Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
- For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment
- There are traceable medical records during treatment.
Who cannot join
- Pregnant or lactating women. Active infection requiring systemic treatment。
- HIV positive
- Suffering from or suspected of suffering from central nervous system diseases.
- Serious heart disease.
- Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
- The investigator considered that the patient was not suitable for in this study, with any other situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy
Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.
Read the detailed description
About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).
- Conditions
- Breast Neoplasms, HER2-positive Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The total rate of CR+PR after the completion of two cycles of treatment.
Measured: From date of randomization until the date at the end of the second treatment cycle (42 days)
Progression-Free Survival (PFS)
The survival time from the date of recruitment to the date of the first documented progression or date of death.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Adverse Events
All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jun 2020
- Primary completion1 May 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367739
- Sponsor's protocol ID
- Real-HER2
- Status last verified
- Jul 2023
- First submitted
- 5 May 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy
- ClinicalTrials.gov ID
- NCT05367739
- Acronym / sponsor ID
- Real-HER2
- Conditions
- Breast Neoplasms, HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 10 May 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.
Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.
Detailed description
About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 positive breast cancer patients who plan to receive anti-HER2 therapy
Key inclusion criteria (8 listed)
- Age ≥ 18 years old, voluntary consent and signed written informed consent.
- ECOG 0~2.
- Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
- At least one measurable disease lesion before treatment.
- Anticipated survival time is longer than three months.
Key exclusion criteria (6 listed)
- Pregnant or lactating women. Active infection requiring systemic treatment。
- HIV positive
- Suffering from or suspected of suffering from central nervous system diseases.
- Serious heart disease.
- Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate (ORR)
Time frame: From date of randomization until the date at the end of the second treatment cycle (42 days)
The total rate of CR+PR after the completion of two cycles of treatment.
Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The survival time from the date of recruitment to the date of the first documented progression or date of death.
Adverse Events
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
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 7 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and HER2-positive Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
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 6 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Objective Response Rate (ORR) (time frame: From date of randomization until the date at the end of the second treatment cycle (42 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.