Breast CancerPhase 2NCT05891561
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
A Phase 2 study testing Pertuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
- HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines
- complete clinical pathological information
- Eastern Cooperative oncology Group [ECOG] 0-1
- Currently not pregnant or breast-feeding
- Fine organ function
- Have good compliance with planned treatment, understand the study process and sign a written informed consent
Who cannot join
- Bilateral or metastatic breast cancer
- Receiving neoadjuvant treatment
- Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infections or other serious illnesses
- HIV infection, active hepatitis B or C infection
- Known allergy to or intolerance to a therapeutic drug or its excipients
Show all 11Show fewer
- Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
- Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
- Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
- History of mental illness or drug abuse that may affect compliance with the trial requirements
- The researchers determine that the patients were not suitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Xiaosong Chen, +8621-64370045*602102
Yiwei Tong, +8621-64370045*602107
About this study
Official title: Short-course Trastuzumab, Pertuzumab Combined with Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
- Conditions
- Breast Cancer
- Being tested
- Pertuzumab
- Keywords
- breast cancer, pertuzumab, her2, adjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
4 cycles of taxane, pertuzumab, trastuzumab
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab | Experimental | 4 cycles of taxane, Pertuzumab, Trastuzumab Receives: Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival [DFS]
Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause
Measured: 3 year
Secondary outcomes (3)
Overall survival [OS]
Time from surgery to death from any cause
Measured: 3 year
Distant disease-free survival [DDFS]
Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause
Measured: 3 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891561
- Sponsor's protocol ID
- RJBC-THP4
- Status last verified
- Mar 2024
- First submitted
- 21 May 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Trastuzumab, Pertuzumab Combined with Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study
- ClinicalTrials.gov ID
- NCT05891561
- Acronym / sponsor ID
- RJBC-THP4
- Conditions
- Breast Cancer
- Keywords
- breast cancer, pertuzumab, her2, adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jun 2023 (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.
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab | Experimental | Drug: Pertuzumab4 cycles of taxane, Pertuzumab, Trastuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
- HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines
- complete clinical pathological information
- Eastern Cooperative oncology Group [ECOG] 0-1
- Currently not pregnant or breast-feeding
Key exclusion criteria (11 listed)
- Bilateral or metastatic breast cancer
- Receiving neoadjuvant treatment
- Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infections or other serious illnesses
- HIV infection, active hepatitis B or C infection
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 |
|---|---|---|
| Pertuzumab4 cycles of taxane, pertuzumab, trastuzumab | Drug | Pertuzumab |
Primary outcome
Disease free survival [DFS]
Time frame: 3 year
Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause
3 secondary outcomes
Overall survival [OS]
Time frame: 3 year
Distant disease-free survival [DDFS]
Time frame: 3 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 year
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 27 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pertuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaosong Chen (+8621-64370045*602102, chenxiaosong0156@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival [DFS] (time frame: 3 year). 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 27 Nov 2024.