Breast CancerPhase 2NCT04138719
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer
A Phase 2 study testing Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Epirubicin in people with Breast Cancer and Triple-negative Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a multicenter, open, randomized, comparison study. 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
- Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel
- What is being tested?
- Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 20 Jun 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 primary invasive breast cancer;
- Histologically confirmed triple negative breast cancer;
- Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
- Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
- Have at least one measurable lesion as per the RECIST criteria (version 1.1);
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- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- LVEF≥55%；
- 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
- Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- 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 Epirubicin in the Neoadjuvant Therapy for Breast Cancer
This is a multicenter, open, randomized, comparison study. 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.
Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.
Read more
The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.
The total number of patients to be included in this study is 520 patients.
- Conditions
- Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel
- Being tested
- Nab-paclitaxel + Carboplatin, Nab-paclitaxel + Epirubicin
- Keywords
- Triple-negative Breast Cancer, Nab-paclitaxel, Carboplatin, Epirubicin
- 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-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 + EpirubicinDrug
nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 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； Receives: Drug: Nab-paclitaxel + Carboplatin |
| Nab-paclitaxel + Epirubicin | Active comparator | nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles； Receives: Drug: Nab-paclitaxel + Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR (pathological complete response)
No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR
Measured: 3 years
Secondary outcomes (3)
Objective response rate (ORR)
Measured: 3 years
Disease free survival（DFS）
Measured: 3 years
Adverse events (AE)
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 posted24 Oct 2019
- Study start20 Nov 2019
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Jun 2028 (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 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
- 520 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
- NCT04138719
- Sponsor's protocol ID
- CSPC-KAL-BC-11
- 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
- No
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 Epirubicin in the Neoadjuvant Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT04138719
- Acronym / sponsor ID
- CSPC-KAL-BC-11
- Conditions
- Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel
- Keywords
- Triple-negative Breast Cancer, Nab-paclitaxel, Carboplatin, Epirubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 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 Oct 2026 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 24 Oct 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 multicenter, open, randomized, comparison study. 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.
Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.
The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.
The total number of patients to be included in this study is 520 patients.
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； |
| Nab-paclitaxel + Epirubicin | Active comparator | Drug: Nab-paclitaxel + Epirubicinnab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles； |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females with age between 18 to 70 years old;
- Histologically confirmed primary invasive breast cancer;
- Histologically confirmed triple negative breast cancer;
- Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
- Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
Key exclusion criteria (8 listed)
- Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- 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;
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 + Epirubicinnab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles； | Drug | Nab-paclitaxel + Epirubicin |
Primary outcome
pCR (pathological complete response)
Time frame: 3 years
No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR
3 secondary outcomes
Objective response rate (ORR)
Time frame: 3 years
Disease free survival（DFS）
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: 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.
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 + Epirubicin in people with Breast Cancer and Triple-negative Breast Cancer, 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 11 inclusion and 8 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?
pCR (pathological complete response) (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.