Breast CancerPhase 4NCT07093931
Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer
A Phase 4 study testing lobaplatin, carboplatin and Docetaxel or albumin paclitaxel in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer. Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- lobaplatin, carboplatin and Docetaxel or albumin paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2030
- Phase
- Phase 4
- 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
- Newly diagnosed breast cancer
- 18-70 Years, female;
- life expectancy is not less than 3 months
- Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 [ HER2 ] positive, estrogen receptor [ ER ] and progesterone receptor [ PR ] negative or positive );
- Stage at presentation: T1c N1-2 or T2-4 N0-2;
- at least one measurable lesion according to RECIST 1.1;
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- Adequate function of major organs meets the following requirements:
- Neutrophils ≥ 1.5×10^9/L
- Platelets ≥ 100×10^9/L
- Hemoglobin ≥ 90g/L
- lymphocyte≥0.5×10^9/L
- Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- ALT and AST ≤ 3 × ULN
- ALP≤ 2.5 × ULN
- BUN and Cr ≤ 1.5 × ULN
- TSH≤ ULN
- Left ventricular ejection fraction (LVEF) ≥ 50%
- QTcF ≤ 470 ms
- Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1); .For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.
Who cannot join
- Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
- Inflammatory breast cancer
- patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
- Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
- Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies .Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Major surgical procedure within 4 weeks prior to initiation of study treatment
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- Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
- Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases
- Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study .Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis
- Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment
- Has evidence of active tuberculosis within 1year prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- Pre-existing motor or sensory neuropathy of a severity≥grade 2
- Has significant cardiovascular disease
- Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
- Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial .History of neurological or psychiatric disorders, including epilepsy or dementia.
- any other situation evaluated by researchers
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
Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences
Shandong, Jinan, 250117
About this study
Official title: A Phase Ⅲ Study to Evaluate Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in Participants With HER-2 Positive Breast Cancer.
The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer.
Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
- Conditions
- Breast Cancer
- Being tested
- lobaplatin, carboplatin, Docetaxel or albumin paclitaxel, Trastuzumab, pertuzumab
- Keywords
- HER-2 positive breast cancer, Pathological Complete Response, Neoadjuvant Therapt, lobaplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lobaplatinDrug
30mg / m2 i.v. q3w
carboplatinDrug
AUC 5-6 i.v. q3w
Docetaxel or albumin paclitaxelDrug
Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )
TrastuzumabDrug
6 cycles of treatment, according to the instructions recommended dosage.
pertuzumabDrug
6 cycles of treatment, according to the instructions recommended dosage.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab | Other | Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) combined with carboplatin ( AUC 5-6 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Receives: Drug: carboplatin; Drug: Docetaxel or albumin paclitaxel; Drug: Trastuzumab; Drug: pertuzumab |
| Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab | Experimental | Docetaxel ( 75mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260mg / m2 i.v. d1, q3w ) combined with lobaplatin ( 30mg / m2 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Receives: Drug: lobaplatin; Drug: Docetaxel or albumin paclitaxel; Drug: Trastuzumab; Drug: pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.
Measured: Up to approximately 27-30 weeks
Adverse events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE.
The type, grade and frequency of AEs will be reported.
Measured: Up to approximately 35 weeks
Secondary outcomes (4)
Event-Free Survival (EFS) in all participants
EFS is defined as the time from start of study treatment to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Measured: Up to approximately 5 years
Objective Overall Response Rate (ORR)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until definitive surgery or disease progression.
Measured: Up to approximately 25-30 weeks
Disease-free survival ( DFS )
DFS is defined as the time interval from the first day of disease-free ( i.e., the date of surgery ) to the first recording of related events, including postoperative disease recurrence and metastasis and death from any cause.
Measured: Up to approximately 5 years
Distant Disease-Free Survival(DDFS)
DDFS is defined as the time interval from the beginning of treatment ( such as surgery, radiotherapy or drug intervention ) to the first occurrence of distant metastasis or death from any cause.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2030 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093931
- Sponsor's protocol ID
- MA-BC-III-HER2+-001
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Study to Evaluate Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in Participants With HER-2 Positive Breast Cancer.
- ClinicalTrials.gov ID
- NCT07093931
- Acronym / sponsor ID
- MA-BC-III-HER2+-001
- Conditions
- Breast Cancer
- Keywords
- HER-2 positive breast cancer, Pathological Complete Response, Neoadjuvant Therapt, lobaplatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 30 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 aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer.
Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab | Other | Drug: carboplatin, Drug: Docetaxel or albumin paclitaxel, Drug: Trastuzumab, Drug: pertuzumabDocetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) combined with carboplatin ( AUC 5-6 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. |
| Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab | Experimental | Drug: lobaplatin, Drug: Docetaxel or albumin paclitaxel, Drug: Trastuzumab, Drug: pertuzumabDocetaxel ( 75mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260mg / m2 i.v. d1, q3w ) combined with lobaplatin ( 30mg / m2 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Newly diagnosed breast cancer
- 18-70 Years, female;
- life expectancy is not less than 3 months
- Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 [ HER2 ] positive, estrogen receptor [ ER ] and progesterone receptor [ PR ] negative or positive );
- Stage at presentation: T1c N1-2 or T2-4 N0-2;
Key exclusion criteria (21 listed)
- Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
- Inflammatory breast cancer
- patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
- Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
- Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies .Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical 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 |
|---|---|---|
| lobaplatin30mg / m2 i.v. q3w | Drug | Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab |
| carboplatinAUC 5-6 i.v. q3w | Drug | Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab |
| Docetaxel or albumin paclitaxelDocetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) | Drug | Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab, Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab |
| Trastuzumab6 cycles of treatment, according to the instructions recommended dosage. | Drug | Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab, Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab |
| pertuzumab6 cycles of treatment, according to the instructions recommended dosage. | Drug | Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab, Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab |
Primary outcome
Pathological Complete Response
Time frame: Up to approximately 27-30 weeks
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.
Adverse events (AEs)
Time frame: Up to approximately 35 weeks
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE. The type, grade and frequency of AEs will be reported.
4 secondary outcomes
Event-Free Survival (EFS) in all participants
Time frame: Up to approximately 5 years
Objective Overall Response Rate (ORR)
Time frame: Up to approximately 25-30 weeks
Disease-free survival ( DFS )
Time frame: Up to approximately 5 years
Distant Disease-Free Survival(DDFS)
Time frame: Up to approximately 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 30 Jul 2025.
- Individual participant dataSharing planned: Yes
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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 4 study testing lobaplatin, carboplatin and Docetaxel or albumin paclitaxel in people with Breast Cancer, run by Shandong Cancer Hospital and Institute 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 19 inclusion and 21 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: opening soon, as of the sponsor's last update on 30 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Yongsheng Wang, MD (+8613505409989, wangysh2008@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: Up to approximately 27-30 weeks). The study lists 2 primary outcomes in all. 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 30 Jul 2025.