HER2-positive Metastatic Breast CancerHELPNCT05188495
Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
An observational study of HER2-positive Metastatic Breast Cancer and Previously Treated With Trastuzumab, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab, Trastuzumab Combined With Pertuzumab and Chemotherapy
- What is being tested?
- trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2021to 10 Dec 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: Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously in first to third line setting
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Adults ≥18 years old
- Histologically confirmed invasive BC: incurable, immunohistochemistry (IHC) 3 + or fish confirmed gene amplification: HER2 / CEP 17 ratio ≥ 2, and either of the two analysis results is positive.
- Patients with metastatic breast cancer previously treated with trastuzumab 1) the number of lines receiving anti-HER2 treatment for metastatic diseases was 0-2 2) If the number of lines previously receiving anti-HER2 treatment for metastatic diseases is 0, it is required that the last time of preoperative( neoadjuvant) and / or postoperative (adjuvant) trastuzumab is more than 6 months before recurrence and metastasis.
- Measurable disease as defined per RECIST v.1.1. Patients with only central nervous system diseases are not suitable for inclusion.
- Left ventricular ejection fraction (LVEF) ≥ 50%, determined by echocardiography.
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Adequate organ and bone marrow function defined as follows,Confirmed by the following laboratory examination results within 7 days before randomization：
- (1) Absolute Neutrophil Count (ANC) ≥1,500/mm3 (1.5 x 109 /L);
- (2)Platelets ≥100,000/mm3 (100 x 109 /L);
- (3) Hemoglobin ≥9 g/dL (90 g/L);（patients are allowed to reach these levels through blood transfusion or drug treatment）
- (4)Albumin ≥ 2.5 g / dl
- (5)Serum creatinine ≤1.5 x Upper Limit of Normal (ULN)
- (6)Total serum bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert's disease);
- (7) AST and/or ALT ≤3 x ULN (≤5.0 x ULN if liver metastases present);
- (8) INR and APTT < 1.5 ´ upper normal limit (ULN) (unless receiving anticoagulant therapy);
- Women with fertility: agree to abstinence (no heterosexual intercourse) or use non hormonal contraceptive methods with an annual failure rate of less than 1% during treatment and at least 7 months after the last administration of the test drug.
- If a female patient is in the late menopause, has not yet reached the postmenopausal state (continuous non menstruation time ≥ 12 months, and there is no other confirmed reason except menopause), and has not received sterilization surgery (removal of ovary and / or uterus), the patient is considered to be fertile.
- Examples of non hormonal contraceptive methods with an annual failure rate of < 1% include bilateral tubal ligation, male contraception and copper ring IUD.
- Barrier contraception must be supplemented by spermicide. Alternatively, use two methods at the same time (e.g. two barrier contraceptives, such as condoms and uterine caps) to achieve an annual failure rate of < 1%.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- History of receivingpatuzumab in the treatment of metastatic diseases (if used during adjuvant or neoadjuvant, the time from the last medication to recurrence and metastasis should be more than 12 months)
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive BC, or cancers with a similar curative outcome as those mentioned above
- History of receiving chemotherapy or trastuzumab within 21 days before randomization (7 days in the case of weekly regimen)
- History of radiation therapy within 14 days before randomization
- Patients must recover from acute toxicity caused by previous treatment (to ≤ grade 1) before randomization.
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- Untreated symptomatic progressive brain metastases occurred within 30 days before randomization.
- The cumulative dose of exposure to the following anthracyclines is detailed as follows:
- Doxorubicin > 500 mg/m2 Epirubucin > 720 mg/m2 Mitoxantrone > 120 mg/m2 If other anthracyclines or several anthracyclines are used, the cumulative dose must be less than the equivalent dose of 500 mg / m2 adriamycin.
- Current unstable ventricular arrhythmia requiring treatment.
- History of symptomatic congestive heart failure（CHF， [NYHA]II-IV级）。
- History of myocardial infarction or unstable angina within 6 months of enrollment
- History of a decrease in LVEF to < 50% or symptomatic CHF with previous trastuzumab treatment
- Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Pregnancy or lactation
- Currently known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
- For patients who are known carriers, active HBV infection must be ruled out. Active HBV infection is defined on the basis of results of three tests: positive HBsAg, detectable HBV DNA, and ALT > ULN.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruyan Zhang
Beijing, Beijing Municipality, 100142
Ruyan Zhang, M.D., +86-010-88196380, zhangruyan2016@163.com
Huiping Li, M.D., +86-010-88196739, huipingli2012@hotmail.com
About this study
Official title: Phase II Study of Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month progression free survival(PFS) of trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy as first to third line therapy in Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously.Primary Endpoint is 6-month Progression-free survival (PFS);Secondary Endpoint(s) include Progression-free survival (PFS) Overall Survival (OS);Objective Response Rate(ORR);
- Conditions
- HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab, Trastuzumab Combined With Pertuzumab and Chemotherapy
- Being tested
- trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and ChemotherapyDrug
trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy； TPC:treatment of physician's choice,include taxanes，Gemcitabine, capecitabine, vinorelbine
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression-free survival (PFS) rate
the proportion of patients who were progression free at 6 months or later. were progression free at 6 months or later.
Measured: from the day treatment started to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 May 2021
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Huiping, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188495
- Sponsor's protocol ID
- 2020KT151
- Acronym
- HELP
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang R, Liu X, Song G, Zhang Y, Li H. Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study. Cancer Res Treat. 2024 Jul;56(3):795-801. doi: 10.4143/crt.2023.1151. Epub 2023 Dec 20.
PubMed 38147816
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
- ClinicalTrials.gov ID
- NCT05188495
- Acronym / sponsor ID
- HELP / 2020KT151
- Conditions
- HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab, Trastuzumab Combined With Pertuzumab and Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 12 Jan 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.
Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month progression free survival(PFS) of trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy as first to third line therapy in Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously.Primary Endpoint is 6-month Progression-free survival (PFS);Secondary Endpoint(s) include Progression-free survival (PFS) Overall Survival (OS);Objective Response Rate(ORR);
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously in first to third line setting
Key inclusion criteria (21 listed)
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- If a female patient is in the late menopause, has not yet reached the postmenopausal state (continuous non menstruation time ≥ 12 months, and there is no other confirmed reason except menopause), and has not received sterilization surgery (removal of ovary and / or uterus), the patient is considered to be fertile.
- Examples of non hormonal contraceptive methods with an annual failure rate of < 1% include bilateral tubal ligation, male contraception and copper ring IUD.
- Barrier contraception must be supplemented by spermicide. Alternatively, use two methods at the same time (e.g. two barrier contraceptives, such as condoms and uterine caps) to achieve an annual failure rate of < 1%.
Key exclusion criteria (18 listed)
- Patients presenting with any of the following will not be included in the study:
- Doxorubicin > 500 mg/m2 Epirubucin > 720 mg/m2 Mitoxantrone > 120 mg/m2 If other anthracyclines or several anthracyclines are used, the cumulative dose must be less than the equivalent dose of 500 mg / m2 adriamycin.
- For patients who are known carriers, active HBV infection must be ruled out. Active HBV infection is defined on the basis of results of three tests: positive HBsAg, detectable HBV DNA, and ALT > ULN.
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 |
|---|---|---|
| trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapytrastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy； TPC:treatment of physician's choice,include taxanes，Gemcitabine, capecitabine, vinorelbine | Drug | – |
Primary outcome
6-month Progression-free survival (PFS) rate
Time frame: from the day treatment started to 6 months
the proportion of patients who were progression free at 6 months or later. were progression free at 6 months or later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 38147816Zhang R, Liu X, Song G, Zhang Y, Li H. Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study. Cancer Res Treat. 2024 Jul;56(3):795-801. doi: 10.4143/crt.2023.1151. Epub 2023 Dec 20.
- Individual participant dataSharing planned: No
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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.
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 HER2-positive Metastatic Breast Cancer and Previously Treated With Trastuzumab, run by Peking University Cancer Hospital & Institute 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 21 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruyan Zhang (+861088196380, zhangruyan2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Progression-free survival (PFS) rate (time frame: from the day treatment started to 6 months). 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 NCT05188495, which also lists 1 linked publication.
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 12 Jan 2022.