Breast Cancer Stage IVPhase 4NCT06578299
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer
A Phase 4 study testing Inetetamab and Paclitaxel ± Pertuzumab in people with Breast Cancer Stage IV, run by Fudan University.
Trial summary
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- Inetetamab and Paclitaxel ± Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 30 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years, female
- Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
- Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
- Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
- ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
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- The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
- Adequate organ function;
- Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
- The patient voluntarily signs an informed consent form.
Who cannot join
- Participated in other clinical trials within 4 weeks;
- Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
- During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
- Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
- Evidence of central nervous system metastasis or leptomeningeal disease;
- Individuals with a known history of allergies to the components of this medication regimen;
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- Pregnant or lactating women;
- Left ventricular ejection fraction<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
- The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.
- Conditions
- Breast Cancer Stage IV
- Being tested
- Inetetamab and Paclitaxel ± Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inetetamab and Paclitaxel ± PertuzumabDrug
Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
| Study group | Role | What they receive |
|---|---|---|
| Inetetamab and Paclitaxel ± Pertuzumab | Experimental | Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Receives: Drug: Inetetamab and Paclitaxel ± Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
Measured: Until progression, assessed up to approximately 24 months
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Until progression, assessed up to approximately 24 months
Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease（SD）>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart.
Measured: Until progression or death, assessed up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study treatment to the date of death.
Measured: Up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Aug 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578299
- Sponsor's protocol ID
- INTPOWER
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）
- ClinicalTrials.gov ID
- NCT06578299
- Acronym / sponsor ID
- INTPOWER
- Conditions
- Breast Cancer Stage IV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 29 Aug 2024 (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.
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
| Arm | Type | Receives |
|---|---|---|
| Inetetamab and Paclitaxel ± Pertuzumab | Experimental | Drug: Inetetamab and Paclitaxel ± PertuzumabInetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 - 70 years, female
- Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
- Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
- Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
Key exclusion criteria (9 listed)
- Participated in other clinical trials within 4 weeks;
- Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
- During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
- Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
- Evidence of central nervous system metastasis or leptomeningeal disease;
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 |
|---|---|---|
| Inetetamab and Paclitaxel ± PertuzumabInetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. | Drug | Inetetamab and Paclitaxel ± Pertuzumab |
Primary outcome
PFS
Time frame: Until progression, assessed up to approximately 24 months
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Until progression, assessed up to approximately 24 months
Clinical Benefit Rate (CBR)
Time frame: Until progression or death, assessed up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inetetamab and Paclitaxel ± Pertuzumab in people with Breast Cancer Stage IV, run by Fudan University.
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 10 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, MD,PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Until progression, assessed up to approximately 24 months). 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 29 Aug 2024.