Breast CancerPhase 3NCT05909332
Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
A Phase 3 study testing Antivascular therapy and Chemotherapy in people with Breast Cancer and Triple Negative Breast Cancer, run by Fudan University at 15 sites in China.
Trial summary
This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype. 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
- What is being tested?
- Antivascular therapy and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 15 sitesChina
- Study dates
- 20 Jun 2023to 30 May 2031
- Phase
- Phase 3
- 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
- Women aged 18-70 years old;
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;
- Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0;
- Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);
- The surgical incision had fully healed prior to the commencement of the study;
- Female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug;
- Sign the Informed Consent Form (ICF). The patient is judged by the investigator to have the ability to comply with the provisions of the protocol.
Who cannot join
- Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)
- Has bilateral breast cancer;
- Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous to randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
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- Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has known allergy to taxane and excipients.
- Has severe or uncontrolled infection;
- Has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders;
- the researchers judged patients to be unsuitable for the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
HuiPing Li, MD, +86-010-88121122
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ting Luo, MD, +86-028-85422114
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Xiaohua Zeng, MD, +86-023-65311341
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
ChuanGui Song, MD, +86-591-83357896
- Recruiting
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, 510062
ShuSen Wang, MD, +86-020-87343292
- Recruiting
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Kun Wang, MD, +86-020-83827812
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006
ZhiXian He, MD, +86-513-85052504
SuJie Ni, MD
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
WeiZhu Wu, MD, +86-574-87018701
- Recruiting
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com
Lei Fan, MD, 86-21-641755901105, cmchen@medmail.com.cn
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233
Zan Shen, MD, +86-021-64369181
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
ZhiGang Zhuang, MD, +86-021-20261000
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
YueE Teng, MD, +86-024-83283333
YingYing Xu, MD
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Tao Shen, MD, +86-024-81916684
Qiang Zhang, MD
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Jin Yang, MD, +86-029-85323217
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009
DeYuan Fu, MD, +86-0514-87373114
About this study
Official title: A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)
This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Antivascular therapy, Chemotherapy
- Keywords
- triple negative breast cancer, adjuvant therapy, antivascular therapy
- 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.
Antivascular therapyDrug
BP102 (anti VEGFR)
ChemotherapyDrug
ddEC-P
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose.
Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. Receives: Drug: Antivascular therapy; Drug: Chemotherapy |
| Arm-B | Active comparator | Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS
invasive disease-free survival
Measured: 5 years
Secondary outcomes (3)
DRFS
distant recurrence free survival
Measured: 5 years
OS
overall survival
Measured: 5 years
AE
adverse effects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 Jun 2023
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2031 (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 Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909332
- Sponsor's protocol ID
- BCTOP-T-A03
- Status last verified
- Jan 2026
- First submitted
- 25 May 2023
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)
- ClinicalTrials.gov ID
- NCT05909332
- Acronym / sponsor ID
- BCTOP-T-A03
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- triple negative breast cancer, adjuvant therapy, antivascular therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 18 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.
This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Drug: Antivascular therapy, Drug: ChemotherapyBP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
| Arm-B | Active comparator | Drug: ChemotherapyChemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 18-70 years old;
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;
- Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0;
- Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula);
Key exclusion criteria (12 listed)
- Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)
- Has bilateral breast cancer;
- Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast 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 |
|---|---|---|
| Antivascular therapyBP102 (anti VEGFR) | Drug | Arm-A |
| ChemotherapyddEC-P | Drug | Arm-A, Arm-B |
Primary outcome
iDFS
Time frame: 5 years
invasive disease-free survival
3 secondary outcomes
DRFS
Time frame: 5 years
OS
Time frame: 5 years
AE
Time frame: 5 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 21 Jan 2026.
- 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antivascular therapy and Chemotherapy in people with Breast Cancer and Triple Negative Breast Cancer, run by Fudan University at 15 sites 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 8 inclusion and 12 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zhi-Ming Shao, MD, PhD (+86-021-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: 5 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 21 Jan 2026.