Breast CancersOPTIMAL-BCNCT07095023
Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer
A study testing Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab in people with Breast Cancers, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 9 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancers
- What is being tested?
- Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 9 sitesChina
- Study dates
- 15 Aug 2025to 30 Jun 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).
- Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9.0 g/dL
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- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN
- Blood urea nitrogen and serum creatinine ≤1.5×ULN
- Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent
Who cannot join
- History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
- Prior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.
- Participation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and/or receipt of investigational drug/device during the trial.
- Major surgery within 28 days prior to the first dose or planned major surgery during the study period.
- History of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.
- Active tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.
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- History of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.
- History of cardiovascular or cerebrovascular diseases, including:
- Unstable angina;
- Clinically significant arrhythmias requiring medication;
- Myocardial infarction within the past 6 months;
- Heart failure or second-degree or higher atrioventricular block;
- Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.
- Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.
- Unsuitability for oral administration of the investigational drug, as judged by the investigator, including:
- Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases;
- Diseases that may affect drug administration, gastric entry, or absorption (e.g., intestinal obstruction, Crohn's disease, ulcerative colitis).
- Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception during the study and for 6 months after the last dose.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality
Zhaoqing Fan, +86-10-88197838, zhqfan@sina.com
- Not yet recruiting
Guangdong Women and children Hospital
Guangzhou, Guangdong
Anqin Zhang, 86-020-39151720, 30542933@qq.com
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Qiang Liu, PhD, 86-13922251256, liuqiang_sysu@163.com
Yudong Li
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Shu Liu, 86-13908516963, Drliushu@163.com
- Not yet recruiting
Hainan Central Hospital
Haikou, Hainan
Ru Chen, 86-18689830722, cr106@163.com
- Not yet recruiting
Guangxi Provincial Cancer Hospital
Nanning, Guangxi
Huawei Yang, 86-13877105955, huawei5955@163.com
- Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong
Jundong Wu, 86-13829663428, wujun-dong@163.com
- Not yet recruiting
Peking University Shenzhen Hospita
Shenzhen
Xiaoling Liu, 86-18319047963, liuxiaoling@alyun.com
- Not yet recruiting
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Ouchen Wang, 86-13957706099, woc099@163.com
About this study
Official title: A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.
Read the detailed description
OPTIMAL-BC is a multicenter, single arm study using a Simon's two-stage design evaluating neoadjuvant treatment with paclitaxel oral solution combined with subcutaneous fixed dose combination (FDC) of pertuzumab and trastuzumab every 3 weeks for 6 cycles. All subjects will undergo surgery in line with local guidelines following neoadjuvant therapy. The primary endpoint is total pathological complete response(tpCR, ypT0/is, ypN0).
- Conditions
- Breast Cancers
- Being tested
- Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel oral solution plus Subcutaneous Pertuzumab/TrastuzumabDrug
Also called DHP107, RMX3001, Liporaxel, pertuzumab, trastuzumab, and hyaluronidase-zzxf
Patients who meet the inclusion criteria will be enrolled and given paclitaxel oral solution and subcutaneous pertuzumab/trastuzumab for neoadjuvant treatment.
Paclitaxel oral solution: 200mg/m2 po bid, D1,D8,D15, q3w. Subcutaneous pertuzumab/trastuzumab: 1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL, q3w.
| Study group | Role | What they receive |
|---|---|---|
| Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab | Experimental | Paclitaxel oral solution plus subcutaneous fixed-dose combination of pertuzumab and trastuzumab Receives: Drug: Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological Complete Response(tpCR)
It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Measured: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
Secondary outcomes (5)
Overall Response Rate(ORR)
Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.1. ORR includes both partial response (PR) and complete response (CR).
Measured: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression during neoadjuvant treatment, disease recurrence, or any cause of death.
Measured: Up to 3 years
Overall survival(OS)
Overall survival is defined as the time from treatment start until death from any cause.
Measured: Up to 3 years
Health Related Quality of Life (QoL)
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using the Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100. For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: From baseline to 30 days after completion of treatment or the last follow-up visit
Adverse Events
Safety will be assessed by evaluating the incidence, and severity of adverse events according to CTCAE 5.0 (Common Terminology Criteria for Adverse Events).
Measured: From first dose of study drug to 30 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University Shenzhen Hospital, Hainan People's Hospital, The Affiliated Hospital Of Guizhou Medical University, Nanfang Hospital, Southern Medical University, Guangdong Women and Children Hospital, Affiliated Cancer Hospital of Shantou University Medical College, First Affiliated Hospital of Wenzhou Medical University, Cancer Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Qiang Liu, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095023
- Sponsor's protocol ID
- SYSKY-2025-397-01
- Acronym
- OPTIMAL-BC
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2025
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07095023
- Acronym / sponsor ID
- OPTIMAL-BC / SYSKY-2025-397-01
- Conditions
- Breast Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University Shenzhen Hospital, Hainan People's Hospital, The Affiliated Hospital Of Guizhou Medical University, Nanfang Hospital, Southern Medical University, Guangdong Women and Children Hospital, Affiliated Cancer Hospital of Shantou University Medical College, First Affiliated Hospital of Wenzhou Medical University, Cancer Hospital of Guangxi Medical University
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 Jul 2025 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.
Detailed description
OPTIMAL-BC is a multicenter, single arm study using a Simon's two-stage design evaluating neoadjuvant treatment with paclitaxel oral solution combined with subcutaneous fixed dose combination (FDC) of pertuzumab and trastuzumab every 3 weeks for 6 cycles. All subjects will undergo surgery in line with local guidelines following neoadjuvant therapy. The primary endpoint is total pathological complete response(tpCR, ypT0/is, ypN0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab | Experimental | Drug: Paclitaxel oral solution plus Subcutaneous Pertuzumab/TrastuzumabPaclitaxel oral solution plus subcutaneous fixed-dose combination of pertuzumab and trastuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).
- Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
Key exclusion criteria (18 listed)
- History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
- Prior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.
- Participation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and/or receipt of investigational drug/device during the trial.
- Major surgery within 28 days prior to the first dose or planned major surgery during the study period.
- History of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.
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 |
|---|---|---|
| Paclitaxel oral solution plus Subcutaneous Pertuzumab/TrastuzumabAlso: DHP107, RMX3001, Liporaxel, pertuzumab, trastuzumab, and hyaluronidase-zzxfPatients who meet the inclusion criteria will be enrolled and given paclitaxel oral solution and subcutaneous pertuzumab/trastuzumab for neoadjuvant treatment. Paclitaxel oral solution: 200mg/m2 po bid, D1,D8,D15, q3w. Subcutaneous pertuzumab/trastuzumab: 1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL, q3w. | Drug | Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab |
Primary outcome
Total Pathological Complete Response(tpCR)
Time frame: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
5 secondary outcomes
Overall Response Rate(ORR)
Time frame: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
Event-Free Survival (EFS)
Time frame: Up to 3 years
Overall survival(OS)
Time frame: Up to 3 years
Health Related Quality of Life (QoL)
Time frame: From baseline to 30 days after completion of treatment or the last follow-up visit
Adverse Events
Time frame: From first dose of study drug to 30 days after completion of treatment
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 29 Apr 2026.
- 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.
Qiang Liu, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab in people with Breast Cancers, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 9 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 10 inclusion and 18 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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 Qiang Liu, PhD (86-13922251256, liuqiang_sysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathological Complete Response(tpCR) (time frame: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)). 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 29 Apr 2026.