Triple Negative Breast CancerPhase 2NCT04159142
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
A Phase 2 study testing Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Capecitabine in people with Triple Negative Breast Cancer and Nab-paclitaxel, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Nab-paclitaxel
- What is being tested?
- Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 20 Sep 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with age between 18 to 70 years old;
- Histologically confirmed triple negative breast cancer;
- No more than one-line prior treatment for locally advanced or metastatic breast cancer;
- Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- Patients with life expectancy of at least 3 months;
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- Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
- Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
- Patients had good compliance with the planned treatment, understood the research process and written informed consent.
Who cannot join
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- Brain metastasis;
- Recurrence or metastasis within 6 months after capecitabine withdrawal;
- Recurrence or metastasis within 6 months after platinum withdrawal;
- Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
- Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
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- Patients who had Grade 2 or above Peripheral neuropathy;
- Patients with severe systemic infection or other serious diseases;
- Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
- Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
- Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
- The researchers considered the patients who were not suitable for enrollment.
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
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Cuizhi Geng, M.D., 0311-6669 6310, gengcuizhi@hotmail.com
About this study
Official title: Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.
The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
- Conditions
- Triple Negative Breast Cancer, Nab-paclitaxel
- Being tested
- Nab-paclitaxel + Carboplatin, Nab-paclitaxel + Capecitabine
- Keywords
- Nab-paclitaxel, Carboplatin, Capecitabine, Triple Negative Breast Cancer, Maintenance therapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel + CarboplatinDrug
nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；
Nab-paclitaxel + CapecitabineDrug
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles；
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel + Carboplatin | Experimental | Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; Receives: Drug: Nab-paclitaxel + Carboplatin |
| Nab-paclitaxel + Capecitabine | Experimental | Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; Receives: Drug: Nab-paclitaxel + Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Up to disease progression or death due to any cause
Measured: 3 years
Secondary outcomes (4)
PFS rate for 6 cycles
From the date of randomization to the end of 6 cycles
Measured: At the end of Cycle 6 (each cycle is 21 days)
Objective response rate (ORR)
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Measured: 3 years
Overall survival (OS)
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Measured: 3 years
Adverse events (AE)
To evaluate the adverse events of patients with advanced triple-negative breast cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start20 Nov 2019
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Cuizhi GENG, Hebei Medical University Fourth Hospital
- Investigators
- Zefei Jiang, M.D., Study chair, Beijing 302 HospitalCuizhi Geng, M.D., Study chair, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159142
- Sponsor's protocol ID
- CSPC-KAL-BC-16
- Status last verified
- Sep 2025
- First submitted
- 23 Oct 2019
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04159142
- Acronym / sponsor ID
- CSPC-KAL-BC-16
- Conditions
- Triple Negative Breast Cancer, Nab-paclitaxel
- Keywords
- Nab-paclitaxel, Carboplatin, Capecitabine, Triple Negative Breast Cancer, Maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 12 Nov 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.
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.
The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel + Carboplatin | Experimental | Drug: Nab-paclitaxel + CarboplatinNab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; |
| Nab-paclitaxel + Capecitabine | Experimental | Drug: Nab-paclitaxel + CapecitabineNab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females with age between 18 to 70 years old;
- Histologically confirmed triple negative breast cancer;
- No more than one-line prior treatment for locally advanced or metastatic breast cancer;
- Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
Key exclusion criteria (13 listed)
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- Brain metastasis;
- Recurrence or metastasis within 6 months after capecitabine withdrawal;
- Recurrence or metastasis within 6 months after platinum withdrawal;
- Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
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-paclitaxel + Carboplatinnab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； | Drug | Nab-paclitaxel + Carboplatin |
| Nab-paclitaxel + CapecitabineNab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； | Drug | Nab-paclitaxel + Capecitabine |
Primary outcome
Progression free survival (PFS)
Time frame: 3 years
Up to disease progression or death due to any cause
4 secondary outcomes
PFS rate for 6 cycles
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Objective response rate (ORR)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Adverse events (AE)
Time frame: 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 11 Sep 2025.
- 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.
Zefei Jiang, M.D. study chair
Beijing 302 Hospital
Cuizhi Geng, M.D. study chair
Hebei Medical University Fourth 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 Nab-paclitaxel + Capecitabine in people with Triple Negative Breast Cancer and Nab-paclitaxel, run by Hebei Medical University Fourth 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 9 inclusion and 13 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 11 Sep 2025. 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 Cuizhi Geng, M.D. (0311-6669 6310, gengcuizhi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 3 years). 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 11 Sep 2025.