HER2-positive Breast CancerNCT07115095
Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
A study testing TP Chemotherapy + Trastuzumab + Pertuzumab and TP Chemotherapy + Trastuzumab in people with HER2-positive Breast Cancer, run by Nanlin Li at 1 site in China.
Trial summary
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade (trastuzumab) in patients with HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- TP Chemotherapy + Trastuzumab + Pertuzumab and TP Chemotherapy + Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HER2-positive breast cancer.
- Presence of measurable lesions.
- No evidence of distant metastases.
- No prior surgery or chemotherapy.
- Voluntarily signed the informed consent form.
Who cannot join
- Incomplete neoadjuvant therapy.
- Incomplete clinical medical records.
- Presence of distant organ metastasis.
- Known allergy to study drugs.
- Expected survival of less than 3 months.
- Significant liver or kidney dysfunction.
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- Presence of hematological or immune system diseases.
- Unclear pathological results.
- Concurrent other malignant tumors.
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum Tumor Markers in Assessing the Efficacy of TP Chemotherapy Combined With Trastuzumab and Pertuzumab Dual Target Therapy in HER2-Positive Breast Cancer
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade (trastuzumab) in patients with HER2-positive breast cancer. The study aims to evaluate treatment response and the clinical value of serum tumor markers (CEA, CA125, and CA153) in assessing therapeutic efficacy.
Read the detailed description
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer accounts for 15-20% of all breast cancers and is associated with a more aggressive disease course. Dual blockade of the HER2 pathway with trastuzumab and pertuzumab, in combination with chemotherapy, has become a standard of care. This study was designed to investigate the added benefit of pertuzumab to a regimen of TP chemotherapy and trastuzumab. Ninety-eight patients with HER2-positive breast cancer were randomized to receive either TP chemotherapy with trastuzumab and pertuzumab (Study Group) or TP chemotherapy with trastuzumab alone (Control Group). The primary objectives were to compare the overall response rate (ORR) and disease control rate (DCR) between the two arms. Secondary objectives included the evaluation of changes in serum tumor marker levels (CEA, CA125, CA153) before and after treatment, the predictive value of these markers for treatment efficacy, and the safety profile of the regimens.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- TP Chemotherapy + Trastuzumab + Pertuzumab, TP Chemotherapy + Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP Chemotherapy + Trastuzumab + PertuzumabDrug
Chemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously and Pertuzumab (initial dose 840 mg, subsequent doses 420 mg) intravenously. This regimen was repeated every 21 days for 6 cycles.
TP Chemotherapy + TrastuzumabDrug
Chemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously. This regimen was repeated every 21 days for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Study Group (Dual-Target Therapy) | Experimental | Patients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days. Receives: Drug: TP Chemotherapy + Trastuzumab + Pertuzumab |
| Active Comparator: Control Group (Single-Target Therapy) | Active comparator | Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days. Receives: Drug: TP Chemotherapy + Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.
Measured: After completion of Cycle 6 (each cycle is 21 days)
Disease Control Rate (DCR)
The proportion of patients with a complete response (CR), partial response (PR), or stable disease (SD) according to iRECIST criteria.
Measured: After completion of Cycle 6 (each cycle is 21 days)
Secondary outcomes (4)
Change in Serum Carcinoembryonic Antigen (CEA) level
Measured from serum samples. Unit: ng/mL.
Measured: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 125 (CA125) level
Measured from serum samples. Unit: U/mL.
Measured: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 153 (CA153) level
Measured from serum samples. Unit: U/mL.
Measured: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Incidence of Treatment-Related Adverse Events
Number of participants experiencing adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Events include liver function abnormalities, hemoglobin reduction, platelet reduction, cardiotoxicity, gastrointestinal symptoms, and joint/muscle pain.
Measured: Monitored throughout the treatment period, from Baseline up to the completion of Cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanlin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nanlin Li, Shaanxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115095
- Sponsor's protocol ID
- KY20202039-C-1
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Tumor Markers in Assessing the Efficacy of TP Chemotherapy Combined With Trastuzumab and Pertuzumab Dual Target Therapy in HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07115095
- Acronym / sponsor ID
- KY20202039-C-1
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Nanlin LiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 11 Aug 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.
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade (trastuzumab) in patients with HER2-positive breast cancer. The study aims to evaluate treatment response and the clinical value of serum tumor markers (CEA, CA125, and CA153) in assessing therapeutic efficacy.
Detailed description
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer accounts for 15-20% of all breast cancers and is associated with a more aggressive disease course. Dual blockade of the HER2 pathway with trastuzumab and pertuzumab, in combination with chemotherapy, has become a standard of care. This study was designed to investigate the added benefit of pertuzumab to a regimen of TP chemotherapy and trastuzumab. Ninety-eight patients with HER2-positive breast cancer were randomized to receive either TP chemotherapy with trastuzumab and pertuzumab (Study Group) or TP chemotherapy with trastuzumab alone (Control Group). The primary objectives were to compare the overall response rate (ORR) and disease control rate (DCR) between the two arms. Secondary objectives included the evaluation of changes in serum tumor marker levels (CEA, CA125, CA153) before and after treatment, the predictive value of these markers for treatment efficacy, and the safety profile of the regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Study Group (Dual-Target Therapy) | Experimental | Drug: TP Chemotherapy + Trastuzumab + PertuzumabPatients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days. |
| Active Comparator: Control Group (Single-Target Therapy) | Active comparator | Drug: TP Chemotherapy + TrastuzumabPatients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed HER2-positive breast cancer.
- Presence of measurable lesions.
- No evidence of distant metastases.
- No prior surgery or chemotherapy.
- Voluntarily signed the informed consent form.
Key exclusion criteria (10 listed)
- Incomplete neoadjuvant therapy.
- Incomplete clinical medical records.
- Presence of distant organ metastasis.
- Known allergy to study drugs.
- Expected survival of less than 3 months.
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 |
|---|---|---|
| TP Chemotherapy + Trastuzumab + PertuzumabChemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously and Pertuzumab (initial dose 840 mg, subsequent doses 420 mg) intravenously. This regimen was repeated every 21 days for 6 cycles. | Drug | Experimental: Study Group (Dual-Target Therapy) |
| TP Chemotherapy + TrastuzumabChemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously. This regimen was repeated every 21 days for 6 cycles. | Drug | Active Comparator: Control Group (Single-Target Therapy) |
Primary outcome
Overall Response Rate (ORR)
Time frame: After completion of Cycle 6 (each cycle is 21 days)
The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.
Disease Control Rate (DCR)
Time frame: After completion of Cycle 6 (each cycle is 21 days)
The proportion of patients with a complete response (CR), partial response (PR), or stable disease (SD) according to iRECIST criteria.
4 secondary outcomes
Change in Serum Carcinoembryonic Antigen (CEA) level
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 125 (CA125) level
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 153 (CA153) level
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Incidence of Treatment-Related Adverse Events
Time frame: Monitored throughout the treatment period, from Baseline up to the completion of Cycle 6 (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TP Chemotherapy + Trastuzumab + Pertuzumab and TP Chemotherapy + Trastuzumab in people with HER2-positive Breast Cancer, run by Nanlin Li 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 11 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: After completion of Cycle 6 (each cycle is 21 days)). 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 11 Aug 2025.