Breast CancerPhase 2NeoPATHNCT03907800
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
A Phase 2 study testing Nab-paclitaxel, Carboplatin and Herceptin in people with Breast Cancer and Triple Negative Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Nab-paclitaxel, Carboplatin and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to Oct 2022
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- Age at diagnosis ≥ 18 years, female.
- Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0.
- cT2-4NanyM0 or cTanyN1-3M0
- ECOG ≤ 1, LVEF ≥ 55%.
- Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
- Patients must be available and compliant for treatment and follow-up.
Who cannot join
- Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
- Known or suspected congestive heart failure (> NYHA I)
- Currently active infection or severe symptomatic visceral disease.
- Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
- rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
- Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Li Zhu, Prof., 0086-21-64370045 ext. 602178, pinkscorpio@163.com
Jiayi Wu, Dr., 0086-21-64370045 ext. 602268, zhuli8@yeah.net
About this study
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
- Being tested
- Nab-paclitaxel, Carboplatin, Herceptin
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
CarboplatinDrug
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
HerceptinDrug
In case of HER2-positive, patients receive Herceptin weekly during all cycles.
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel + Carboplatin ± Herceptin | Experimental | Not described Receives: Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (ypT0/is ypN0) rate
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Measured: 16 weeks (at the time of definitive surgery)
Secondary outcomes (5)
Invasive disease-free survival (IDFS)
IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Measured: 5 years
Distant disease-free survival (DDFS)
DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)
Measured: 5 years
Objective response rate (ORR)
ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1
Measured: 16 weeks (at the time of definitive surgery)
Breast conservation rate
To determine the breast conservation rate after neoadjuvant treatment.
Measured: 16 weeks (at the time of definitive surgery)
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Measured: during treatment (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2019
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhu, Ruijin Hospital
- Investigators
- Li Zhu, Prof., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907800
- Sponsor's protocol ID
- RJBC1801
- Acronym
- NeoPATH
- Status last verified
- Oct 2022
- First submitted
- 5 Apr 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
Wu J, Liu D, Chen M, Lin C, Ding S, Hong J, Gao W, Zhu S, Chen X, Huang O, He J, Chen W, Li Y, Shen K, Zhu L. Anthracycline-Free Neoadjuvant Therapy With Nab-Paclitaxel and Carboplatin in Non-Luminal Breast Cancer: A Single-Arm Clinical Trial. Int J Cancer. 2026 Aug 17. doi: 10.1002/ijc.70666. Online ahead of print.
PubMed 42608991
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03907800
- Acronym / sponsor ID
- NeoPATH / RJBC1801
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 9 Apr 2019 (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.
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel + Carboplatin ± Herceptin | Experimental | Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: Herceptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- Age at diagnosis ≥ 18 years, female.
- Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0.
- cT2-4NanyM0 or cTanyN1-3M0
- ECOG ≤ 1, LVEF ≥ 55%.
Key exclusion criteria (7 listed)
- Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
- Known or suspected congestive heart failure (> NYHA I)
- Currently active infection or severe symptomatic visceral disease.
- Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
- rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
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 |
|---|---|---|
| Nab-paclitaxel125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles. | Drug | Nab-paclitaxel + Carboplatin ± Herceptin |
| CarboplatinAUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles | Drug | Nab-paclitaxel + Carboplatin ± Herceptin |
| HerceptinIn case of HER2-positive, patients receive Herceptin weekly during all cycles. | Drug | Nab-paclitaxel + Carboplatin ± Herceptin |
Primary outcome
Pathological complete response (ypT0/is ypN0) rate
Time frame: 16 weeks (at the time of definitive surgery)
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
5 secondary outcomes
Invasive disease-free survival (IDFS)
Time frame: 5 years
Distant disease-free survival (DDFS)
Time frame: 5 years
Objective response rate (ORR)
Time frame: 16 weeks (at the time of definitive surgery)
Breast conservation rate
Time frame: 16 weeks (at the time of definitive surgery)
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Time frame: during treatment (16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 42608991Wu J, Liu D, Chen M, Lin C, Ding S, Hong J, Gao W, Zhu S, Chen X, Huang O, He J, Chen W, Li Y, Shen K, Zhu L. Anthracycline-Free Neoadjuvant Therapy With Nab-Paclitaxel and Carboplatin in Non-Luminal Breast Cancer: A Single-Arm Clinical Trial. Int J Cancer. 2026 Aug 17. doi: 10.1002/ijc.70666. Online ahead of print.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Li Zhu, Prof. principal investigator
Ruijin Hospital
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 Nab-paclitaxel, Carboplatin and Herceptin in people with Breast Cancer and Triple Negative Breast Cancer, run by Ruijin 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 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Wu, Dr. (0086-21-64370045 ext. 602268, pinkscorpio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (ypT0/is ypN0) rate (time frame: 16 weeks (at the time of definitive surgery)). 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 NCT03907800, 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 27 Oct 2022.