Her-2 Negative Breast CancerPhase 2IMPARPNCT05761470
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
A Phase 2 study testing Camrelizumab, Fluzoparib and Nab-paclitaxel in people with Her-2 Negative Breast Cancer and HRR Gene Mutation, run by Ying Lin at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Her-2 Negative Breast Cancer, HRR Gene Mutation
- What is being tested?
- Camrelizumab, Fluzoparib and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2022to 31 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented Her-2 negative
- TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
- No distant metastatic disease
- Eastern Cooperative Oncology Group Performance Status: 0~1
- HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
Who cannot join
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
- Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
- Patients who have used immunosuppressive drug or corticosteroids within 14 days.
- Patients who have other diseases which researchers.
- Patients who allergy to any of the drugs in this trail.
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
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Ying Lin, MD, +8602087755766 ext. 8212, linying3@mail.sysu.edu.cn
About this study
Official title: A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
Read the detailed description
This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.
Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.
HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
- Conditions
- Her-2 Negative Breast Cancer, HRR Gene Mutation
- Being tested
- Camrelizumab, Fluzoparib, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle.
Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.
FluzoparibDrug
Fluzoparib
Nab-paclitaxelDrug
Nab-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab, Fluzoparib and Nab-paclitaxel | Experimental | Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle. Receives: Drug: Camrelizumab; Drug: Fluzoparib; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
Measured: Up to 32 weeks
Secondary outcomes (5)
Objective Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response and Partial Response
Measured: Up to 32 weeks
Residual Cancer Burden (RCB)
Pathologilly assessed residual cancer burden according to MD Anderson protocol.
Measured: Up to 32 weeks
Event-Free Survival (EFS)
EFS was defined as the time from the date of randomization to the date of events from any cause.
Measured: Up to 20 years
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Measured: Up to 20 years
Safety of drugs
Adverse effects of the candidates according to NCI-CTCAE 5.0
Measured: Up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start6 May 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her-2 Negative Breast CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ying Lin, MD, Study chair, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761470
- Sponsor's protocol ID
- 20220430GD
- Acronym
- IMPARP
- Status last verified
- Mar 2023
- First submitted
- 24 Dec 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation
- ClinicalTrials.gov ID
- NCT05761470
- Acronym / sponsor ID
- IMPARP / 20220430GD
- Conditions
- Her-2 Negative Breast Cancer, HRR Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ying LinUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Mar 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.
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
Detailed description
This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.
Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.
HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab, Fluzoparib and Nab-paclitaxel | Experimental | Drug: Camrelizumab, Drug: Fluzoparib, Drug: Nab-paclitaxelParticipants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically documented Her-2 negative
- TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
- No distant metastatic disease
- Eastern Cooperative Oncology Group Performance Status: 0~1
- HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
Key exclusion criteria (7 listed)
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
- Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
- Patients who have used immunosuppressive drug or corticosteroids within 14 days.
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 |
|---|---|---|
| CamrelizumabCamrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle. Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle. | Drug | Camrelizumab, Fluzoparib and Nab-paclitaxel |
| FluzoparibFluzoparib | Drug | Camrelizumab, Fluzoparib and Nab-paclitaxel |
| Nab-paclitaxelNab-paclitaxel | Drug | Camrelizumab, Fluzoparib and Nab-paclitaxel |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: Up to 32 weeks
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 32 weeks
Residual Cancer Burden (RCB)
Time frame: Up to 32 weeks
Event-Free Survival (EFS)
Time frame: Up to 20 years
Overall Survival (OS)
Time frame: Up to 20 years
Safety of drugs
Time frame: Up to 32 weeks
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 9 Mar 2023.
- 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.
Ying Lin, MD study chair
Principal Investigator
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 Camrelizumab, Fluzoparib and Nab-paclitaxel in people with Her-2 Negative Breast Cancer and HRR Gene Mutation, run by Ying Lin 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 5 inclusion and 7 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 9 Mar 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.
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 Ying Lin, MD (+8602087755766 ext. 8212, linying3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: Up to 32 weeks). 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 9 Mar 2023.