HER 2 Positive Advanced Breast CancerPhase 2NCT07848633
HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy
A Phase 2 study testing - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles in people with HER 2 Positive Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER 2 Positive Advanced Breast Cancer
- What is being tested?
- - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and reliable contraception must be used throughout the study treatment period.
- Histopathologically confirmed invasive breast cancer, staged as stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2 (3+) confirmed by immunohistochemistry.
- Have at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- No prior history of breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Voluntarily sign and date the written informed consent form.
Show all 11Show fewer
- Adequate organ function meeting the following laboratory criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5×10⁹/L, platelet count ≥ 100×10⁹/L, neutrophil count ≥ 1.5×10⁹/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 1.5× ULN; serum creatinine ≤ 1.5× ULN.
- No myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) cardiac function class I; left ventricular ejection fraction (LVEF) ≥ 55% on echocardiography; cardiac biomarkers including cardiac troponin I (cTnI) and B-type natriuretic peptide (BNP) within normal reference ranges.
- Complete all required baseline laboratory and radiological examinations prior to neoadjuvant treatment initiation.
- No difficulty in swallowing.
- Complete and available clinical medical records.
Who cannot join
- Male breast cancer or inflammatory breast cancer.
- Metastatic breast cancer (Stage IV).
- Concurrent malignancy or a history of any other malignant tumor within the past 5 years, except for adequately treated and controlled basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- Receiving concurrent anti-tumor therapy or participating in any other clinical trial.
- Presence of severe non-malignant diseases that may affect patient compliance or pose potential safety risks.
- Underwent major surgery within 4 weeks prior to study treatment initiation or planned to receive major surgery during the study period.
Show all 11Show fewer
- Received breast cancer-related radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major breast surgery within 4 weeks before treatment initiation; have current or prior exposure to HER2-targeted monoclonal antibodies or tyrosine kinase inhibitors (TKIs), including trastuzumab, pertuzumab, pyrotinib, neratinib, and lapatinib.
- History of allergic reactions or contraindications to any component of the study drugs.
- Presence of chronic diarrhea, intestinal obstruction, or any other disease that may affect drug administration and absorption.
- Uncontrolled cardiac diseases or clinical symptoms, including NYHA class II or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
- Dementia, cognitive impairment, or any psychiatric disorder that hinders the understanding and signing of informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Oral Paclitaxel Solution Combined With Subcutaneous Pertuzumab and Trastuzumab for Neoadjuvant Treatment of HER2-Positive Breast Cancer：A Multicenter, Single-Arm, Phase 2 Clinical Study
- The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety profile, breast-conserving surgery rate after neoadjuvant therapy, and long-term efficacy of this combination regimen.
- Study Interventions All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows:
- Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles.
- Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab). After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines.
Read more
- Participant Procedures (Consistent with Provided Example Structure) The main questions this study aims to answer are:
- Does oral paclitaxel solution combined with subcutaneous dual HER2 blockade improve the pCR rate in patients with HER2-positive early or locally advanced breast cancer?
- What are the safety profiles and tolerability of this oral chemotherapy plus subcutaneous targeted combination regimen?
- Can this regimen improve breast-conserving surgery rate and provide favorable long-term survival outcomes?
- Participants will:
- Take oral paclitaxel solution and receive subcutaneous dual-target injection per study schedule for 6 neoadjuvant cycles
- Complete regular on-site clinic visits, physical examinations, and laboratory tests throughout the treatment period
- Undergo standardized pathological evaluation after neoadjuvant therapy and receive subsequent surgical treatment
- Accept long-term follow-up for survival status and adverse event monitoring
- Conditions
- HER 2 Positive Advanced Breast Cancer
- Being tested
- - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cyclesDrug
All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows:
- Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles.
- Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab).
After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Oral Paclitaxel Solution Plus Subcutaneous Pertuzumab and Trastuzumab | Experimental | Not described Receives: Drug: - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR) rate
Measured: The assessment time frame is the first 6 months after study initiation.
Secondary outcomes (1)
safety profile, breast-conserving surgery rate
- Safety profile of the combination regimen
- Breast-conserving surgery rate in patients after neoadjuvant therapy
- Long-term efficacy of the combination regimen
Measured: The assessment time frame is the first 6 months after study initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HER 2 Positive Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Zhou, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848633
- Sponsor's protocol ID
- NJMU-BC16
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC. Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol. 2018 May 1;29(5):1220-1226. doi: 10.1093/annonc/mdy055.
PubMed 29438463Hong JW, Lee IH, Kwak YH, Park YT, Sung HC, Kwon IC, Chung H. Efficacy and tissue distribution of DHP107, an oral paclitaxel formulation. Mol Cancer Ther. 2007 Dec;6(12 Pt 1):3239-47. doi: 10.1158/1535-7163.MCT-07-0261.
PubMed 18089717Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21.
PubMed 33357420Yang ZJ, Xin F, Chen ZJ, Yu Y, Wang X, Cao XC. Real-world data on neoadjuvant chemotherapy with dual-anti HER2 therapy in HER2 positive breast cancer. BMC Cancer. 2024 Jan 25;24(1):134. doi: 10.1186/s12885-024-11871-0.
PubMed 38273267Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi GV, Magazzu D, McNally V, Douthwaite H, Ross G, Valagussa P. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016 Jun;17(6):791-800. doi: 10.1016/S1470-2045(16)00163-7. Epub 2016 May 11.
PubMed 27179402Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.
PubMed 22153890Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.
PubMed 24101045Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.
PubMed 39817679
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Paclitaxel Solution Combined With Subcutaneous Pertuzumab and Trastuzumab for Neoadjuvant Treatment of HER2-Positive Breast Cancer：A Multicenter, Single-Arm, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT07848633
- Acronym / sponsor ID
- NJMU-BC16
- Conditions
- HER 2 Positive Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Sep 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.
- The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety profile, breast-conserving surgery rate after neoadjuvant therapy, and long-term efficacy of this combination regimen.
- Study Interventions All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows:
- Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles.
- Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab). After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines.
- Participant Procedures (Consistent with Provided Example Structure) The main questions this study aims to answer are:
- Does oral paclitaxel solution combined with subcutaneous dual HER2 blockade improve the pCR rate in patients with HER2-positive early or locally advanced breast cancer?
- What are the safety profiles and tolerability of this oral chemotherapy plus subcutaneous targeted combination regimen?
- Can this regimen improve breast-conserving surgery rate and provide favorable long-term survival outcomes?
- Participants will:
- Take oral paclitaxel solution and receive subcutaneous dual-target injection per study schedule for 6 neoadjuvant cycles
- Complete regular on-site clinic visits, physical examinations, and laboratory tests throughout the treatment period
- Undergo standardized pathological evaluation after neoadjuvant therapy and receive subsequent surgical treatment
- Accept long-term follow-up for survival status and adverse event monitoring
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 Solution Plus Subcutaneous Pertuzumab and Trastuzumab | Experimental | Drug: - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged ≥ 18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and reliable contraception must be used throughout the study treatment period.
- Histopathologically confirmed invasive breast cancer, staged as stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2 (3+) confirmed by immunohistochemistry.
- Have at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- No prior history of breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (11 listed)
- Male breast cancer or inflammatory breast cancer.
- Metastatic breast cancer (Stage IV).
- Concurrent malignancy or a history of any other malignant tumor within the past 5 years, except for adequately treated and controlled basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- Receiving concurrent anti-tumor therapy or participating in any other clinical trial.
- Presence of severe non-malignant diseases that may affect patient compliance or pose potential safety risks.
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 |
|---|---|---|
| - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cyclesAll enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows: * Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles. * Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab). After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines. | Drug | Oral Paclitaxel Solution Plus Subcutaneous Pertuzumab and Trastuzumab |
Primary outcome
pathological complete response (pCR) rate
Time frame: The assessment time frame is the first 6 months after study initiation.
1 secondary outcome
safety profile, breast-conserving surgery rate
Time frame: The assessment time frame is the first 6 months after study initiation.
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 Sep 2026.
- Results publication: PubMed 29438463Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC. Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol. 2018 May 1;29(5):1220-1226. doi: 10.1093/annonc/mdy055.
- Results publication: PubMed 18089717Hong JW, Lee IH, Kwak YH, Park YT, Sung HC, Kwon IC, Chung H. Efficacy and tissue distribution of DHP107, an oral paclitaxel formulation. Mol Cancer Ther. 2007 Dec;6(12 Pt 1):3239-47. doi: 10.1158/1535-7163.MCT-07-0261.
- Results publication: PubMed 33357420Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21.
- Results publication: PubMed 38273267Yang ZJ, Xin F, Chen ZJ, Yu Y, Wang X, Cao XC. Real-world data on neoadjuvant chemotherapy with dual-anti HER2 therapy in HER2 positive breast cancer. BMC Cancer. 2024 Jan 25;24(1):134. doi: 10.1186/s12885-024-11871-0.
- Results publication: PubMed 27179402Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi GV, Magazzu D, McNally V, Douthwaite H, Ross G, Valagussa P. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016 Jun;17(6):791-800. doi: 10.1016/S1470-2045(16)00163-7. Epub 2016 May 11.
- Results publication: PubMed 22153890Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.
- Results publication: PubMed 24101045Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.
- Results publication: PubMed 39817679Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles in people with HER 2 Positive Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 11 inclusion and 11 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wenbin Zhou, PHD (+86 025-68308162, zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (pCR) rate (time frame: The assessment time frame is the first 6 months after study initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07848633, which also lists 8 linked publications.
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 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.