Breast CancerPhase 3NCT07648914
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
A Phase 3 study testing BL-B01D1, Albumin-Bound Paclitaxel and Paclitaxel in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after failure of prior endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BL-B01D1, Albumin-Bound Paclitaxel and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2026to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age ≥ 18 years;
- Expected survival time ≥ 3 months;
- Patients with unresectable locally advanced, recurrent, or metastatic HR+ HER2- breast cancer;
- Trial participants have not received systemic chemotherapy;
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- Trial participants have progressed after at least one line of endocrine therapy, etc.;
- Documented radiographic disease progression prior to enrollment;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 3 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
- Must meet required organ function levels;
- Urinary protein ≤ 2+ or < 1000 mg/24h;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
Who cannot join
- Previously treated with ADC drugs that use topoisomerase I inhibitors as the toxin or target EGFR and/or HER3;
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
- Previous treatment with anthracycline drugs where the equivalent cumulative dose of doxorubicin exceeds 360 mg/m²;
- History of severe cardiovascular or cerebrovascular diseases;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, etc.;
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- Diagnosis of another malignancy within 3 years before the first dose;
- Hypertension poorly controlled by two antihypertensive medications;
- Poorly controlled blood glucose levels;
- History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, etc.;
- Concurrent pulmonary diseases causing clinically severe respiratory function impairment;
- Patients with active central nervous system metastases;
- Presence of large serous cavity effusions or symptomatic serous cavity effusions, etc.;
- Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
- Severe infection within 4 weeks before study randomization;
- Severe, unhealed wounds, ulcers, or fractures within 4 weeks before signing the informed consent form;
- Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing the informed consent form;
- History of inflammatory bowel disease, extensive bowel resection, etc.;
- Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-B01D1 or any of its excipients;
- History of autologous or allogeneic stem cell transplantation;
- Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
- Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;
- Trial participants planning to receive or having received live vaccines within 28 days before the first dose;
- Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial due to complications or other reasons.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Binghei Xu
About this study
Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after failure of prior endocrine therapy.
Read the detailed description
In this trial, the experimental group receives BL-B01D1, and the control group receives chemotherapy of physician's choice.
- Conditions
- Breast Cancer
- Being tested
- BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion for a cycle of 3 weeks.
Albumin-Bound PaclitaxelDrug
Administration by intravenous infusion for a cycle of 4 weeks.
PaclitaxelDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CapecitabineDrug
Oral administration for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1 | Experimental | Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-B01D1 |
| Albumin-bound paclitaxel, paclitaxel, or capecitabine | Active comparator | Participants receive Albumin-bound paclitaxel, paclitaxel, or capecitabine in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: Albumin-Bound Paclitaxel; Drug: Paclitaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Secondary outcomes (6)
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start6 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 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 Sichuan Baili Pharmaceutical Co., Ltd.The 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
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648914
- Sponsor's protocol ID
- BL-B01D1-321
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
- ClinicalTrials.gov ID
- NCT07648914
- Acronym / sponsor ID
- BL-B01D1-321
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (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 trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after failure of prior endocrine therapy.
Detailed description
In this trial, the experimental group receives BL-B01D1, and the control group receives chemotherapy of physician's choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1 | Experimental | Drug: BL-B01D1Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
| Albumin-bound paclitaxel, paclitaxel, or capecitabine | Active comparator | Drug: Albumin-Bound Paclitaxel, Drug: Paclitaxel, Drug: CapecitabineParticipants receive Albumin-bound paclitaxel, paclitaxel, or capecitabine in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age ≥ 18 years;
- Expected survival time ≥ 3 months;
- Patients with unresectable locally advanced, recurrent, or metastatic HR+ HER2- breast cancer;
Key exclusion criteria (24 listed)
- Previously treated with ADC drugs that use topoisomerase I inhibitors as the toxin or target EGFR and/or HER3;
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
- Previous treatment with anthracycline drugs where the equivalent cumulative dose of doxorubicin exceeds 360 mg/m²;
- History of severe cardiovascular or cerebrovascular diseases;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
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 |
|---|---|---|
| BL-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1 |
| Albumin-Bound PaclitaxelAdministration by intravenous infusion for a cycle of 4 weeks. | Drug | Albumin-bound paclitaxel, paclitaxel, or capecitabine |
| PaclitaxelAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Albumin-bound paclitaxel, paclitaxel, or capecitabine |
| CapecitabineOral administration for a cycle of 3 weeks. | Drug | Albumin-bound paclitaxel, paclitaxel, or capecitabine |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
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 23 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-B01D1, Albumin-Bound Paclitaxel and Paclitaxel in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. 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 16 inclusion and 24 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 23 Jul 2026. 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 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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.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: Up to approximately 24 months). 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 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.