HER-2 Positive Breast CancerPhase 2UC HERNCT07565324
Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial)
A Phase 2 study testing Lipo-Dox®, Cyclophosphamide and Trastuzumab (Herceptin) in people with HER-2 Positive Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined with chemotherapy, certain patients did not achieve pCR after receiving dual blockade or… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- HER-2 Positive Breast Cancer
- What is being tested?
- Lipo-Dox®, Cyclophosphamide and Trastuzumab (Herceptin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2026to 31 Dec 2032
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: HER2-positive Primary Invasive Breast Cancer
- Patients must meet the following criteria for study entry:
- Histologically confirmed invasive breast carcinoma
- HER2-positive breast carcinoma
- HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by fluorescence in situ hybridization (FISH) prospectively confirmed by a pathology laboratory before study enrollment.
- FISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for chromosome 17 copies.
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- Clinical stage at presentation: T1-4, N0-3, M0 (T1N0M0 tumors will not be eligible)
- Patients must be willing to receive preoperative systemic chemotherapy with taxanes and HER-2-targeting treatment for at least 4 to 6 cycles.
- Systemic therapy must consist of at least 4 to 6 cycles of chemotherapy with taxanes plus trastuzumab (TH) or
- Systemic therapy must consist of at least 4 to 6 cycles of chemotherapy with taxanes plus trastuzumab and pertuzumab (THP).
- After completion of 4 to 6 cycles of TH or THP, if the following clinical features and pathological characteristics are eligible for Lipo-Dox® and cyclophosphamide plus trastuzumab and pertuzumab:
- c.1 Core biopsy showed the residual invasive breast cancer. c.2 Breast echo or other imaging studies disclosed no complete remission. c.3 Complete remission of core biopsy or breast echo or other imaging studies, but positive for ctDNA.
- Age ≥ 20 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function during screening, included:
- Absolute neutrophil count ≥ 1,200 cells/mm3
- Platelet count ≥ 100,000 cells/ mm3
- Hemoglobin ≥ 9.0 g/dL;
- Serum creatinine < 1.5 × upper limit of normal (ULN)
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 ×ULN
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN
- Serum total bilirubin (TBILI) ≤ 1.0 ×ULN (within normal limits)
- Serum alkaline phosphatase (ALK) ≤ 1.5 ×ULN
- Screening LVEF ≥ 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) before receiving neoadjuvant chemotherapy with 4 to 6 courses of TH or THP and no decrease in LVEF by more than 10% absolute points from the pre-chemotherapy LVEF after 4 to 6 courses of TH or THP.
- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug.
- Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes HB surface antigen (HBsAg) and/or total HB core antibody (anti-HBc) in addition to HCV antibody testing. If positive for HBsAg or positive for Anti-HBc, DNA testing for HBV will be performed. If active HBV infection is ruled out, the patient may be eligible. The most recent serologic testing must have occurred within 3 months prior to initiation of neoadjuvant therapy. If such testing has not been done, it must be performed during screening.
- They should receive examination of HBV DNA to document no active HBV activation (if HBeAg-positive, or HBeAg-negative but abnormal liver function accompanied by ALT ≥ 2 normal limits during the half a year and HBV DNA > 2000 IU/ml: indication of HBV activation). If test of HBsAg is positive and inactive, and they should receive prophylactic anti-HBV drugs during the enrollment period of this clinical trial.
Who cannot join
- Stage IV (metastatic) breast cancer.
- History of any prior (ipsilateral- or contralateral) breast cancer except lobular carcinoma in situ.
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.
- Patients for whom radiotherapy would be recommended for breast cancer treatment, but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation).
- Current NCI common terminology criteria for adverse events (CTCAE) (Version 4.0): Grade ≥ 2 peripheral neuropathy.
- Cardiopulmonary dysfunction as defined by any of the following:
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- History of NCI CTCAE (Version 4.0): Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II.
- Prior treatment with anthracycline or Lipo-Dox®
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers).
- For female patients, current pregnancy and/or lactation. 10. Any known active liver disease, for example, due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis.
- Patients who have positive HBV or HCV serologies without known active disease must meet the eligibility criteria for liver function on at least two consecutive occasions, separated by at least 1 week, within the 30 days-screening period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chiun-Sheng Huang, M.D.,Ph.D. contact
About this study
Official title: Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer
Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined with chemotherapy, certain patients did not achieve pCR after receiving dual blockade or single blockade targeting HER2 combined with taxanes.
Based on the cardiac safety and promising ORR rate of the regimens consisting of PLD and cyclophosphamide and trastuzumab in treating patients with HER2-positive breast cancer in the neoadjuvant or metastatic setting, the investigators hypothesized that dual blockades targeting HER2, trastuzumab and pertuzumab, combined with PLD and cyclophosphamide, will not only increase the pCR rate but also cause less cardiotoxicity for participants with residual cancer via core biopsy or non-clinical CR after receiving taxanes plus trastuzumab and pertuzumab or taxanes plus trastuzumab. The investigators also showed that ctDNA served as the surrogate prognostic marker for participants with HER2-positive EBC who received neoadjuvant trastuzumab-based regimens.
In this study, the investigators will explore whether the combination of PLD (Lipo-Dox®, Liposomal Doxorubicin Injection), cyclophosphamide, trastuzumab, and pertuzumab can increase the pCR rate of participants with HER2-positive EBC if they have residual cancers (core biopsy, non-clinical CR, or positive ctDNA) after receiving a trastuzumab and taxanes-based NAT regimen. In addition, the cardiac safety, adverse effects, and clearance of ctDNA will be explored for these patients. The investigators further assess the feasibility of VAB (before operation) in these participants who achieved negative ctDNA after receiving Lipo-Dox® plus cyclophosphamide, trastuzumab, and pertuzumab.
- Conditions
- HER-2 Positive Breast Cancer
- Being tested
- Lipo-Dox®, Cyclophosphamide, Trastuzumab (Herceptin), Pertuzumab
- Keywords
- HER2, Breast cancer, Lipodox, Cyclophosphamide, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipo-Dox®Drug
Lipo-Dox®: 37.5 mg/m² on D1; every 21 days is one cycle, for a total of 4 cycles.
CyclophosphamideDrug
Cyclophosphamide 600 mg/m² on D1, ; every 21 days is one cycle, for a total of 4 cycles.
Trastuzumab (Herceptin)Drug
Trastuzumab 6 mg/kg on D2; every 21 days is one cycle, for a total of 4 cycles.
PertuzumabDrug
Pertuzumab 420 mg on D2; every 21 days is one cycle, for a total of 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients | Experimental | Not described Receives: Drug: Lipo-Dox®; Drug: Cyclophosphamide; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission rate (pCR)
Assessment of pathological specimens to determine when no cancer cells are detected in tissue samples (breast and lymph nodes) removed during surgery following preoperative treatment, such as chemotherapy.
Measured: From enrollment to the end of operation.
Secondary outcomes (4)
Number of participants with Lipodox-containing regimen-related adverse events of cardiac function as assessed by CTCAE v4.0
Cardiac echo to assess the left ventricle ejection fractions before and after completion of Lipo-Dox®-containing regimen
Measured: From enrollment, before and after completion of Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab, and 12 months after operation.
Clearance rate of circulating tumor DNA [ctDNA]
Circulating tumor DNA (ctDNA) clearance refers to the transition from a detectable level of tumor-specific mutations in the bloodstream to undetectable levels following neoadjuvant treatment, including TH or THP regimen, or Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab.
Measured: From enrollment, completion of TH or THP regimens, completion of Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab, and at the end of operation.
Number of participants with treatment with Lipo-Dox®-containing regimen-related adverse events as assessed by CTCAE v4.0.
Adverse events of Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab.
Measured: From starting a Lipo-Dox®-containing regimen to the end of treatment at 4 weeks.
Percentage of patients with complete removal of lesion via vacuum-assisted biopsy
Comparison of the percentage of patients with a lack of pathology at the surgery between vacuum-assisted biopsy and surgical operation (ctDNAs are negative after completion of neoadjuvant chemotherapy).
Measured: After completion of neoadjuvant chemotherapy regimens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TTY Biopharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565324
- Sponsor's protocol ID
- 202509103MINB
- Acronym
- UC HER
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Gianni 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 22153890van der Voort A, van Ramshorst MS, van Werkhoven ED, Mandjes IA, Kemper I, Vulink AJ, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS. Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 Randomized, Phase 3 Trial. JAMA Oncol. 2021 Jul 1;7(7):978-984. doi: 10.1001/jamaoncol.2021.1371.
PubMed 34014249Tseng LM, Chen FM, Chen ST, Cheng FT, Chao TY, Dai MS, Kao WY, Yeh MH, Chen DR, Liu LC, Wang HC, Chang HT, Wang BW, Yu JC, Chen SC, Liao GS, Hou MF. Comparison of the Efficacy, Safety, and Quality of Life of Pegylated Liposomal Doxorubicin-Cyclophosphamide versus Epirubicin-Cyclophosphamide in Patients with Early-Stage HER2-Negative Breast Cancer: A Prospective, Randomized, Multicenter, Phase II Study. Oncol Res Treat. 2024;47(10):484-495. doi: 10.1159/000540369. Epub 2024 Jul 19.
PubMed 39033747Lin PH, Tsai LW, Lo C, Kuo SH, Ni CC, Yu CH, Huang CS. ctDNA Detected after Neoadjuvant Therapy for HER2-Positive Breast Cancer Is Associated with Inferior Outcomes and May Inform Adjuvant Therapy. Cancer Res Commun. 2026 Jan 1;6(1):105-114. doi: 10.1158/2767-9764.CRC-24-0234.
PubMed 41543393
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07565324
- Acronym / sponsor ID
- UC HER / 202509103MINB
- Conditions
- HER-2 Positive Breast Cancer
- Keywords
- HER2, Breast cancer, Lipodox, Cyclophosphamide, Trastuzumab, Pertuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- TTY Biopharm
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 4 May 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.
Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined with chemotherapy, certain patients did not achieve pCR after receiving dual blockade or single blockade targeting HER2 combined with taxanes.
Based on the cardiac safety and promising ORR rate of the regimens consisting of PLD and cyclophosphamide and trastuzumab in treating patients with HER2-positive breast cancer in the neoadjuvant or metastatic setting, the investigators hypothesized that dual blockades targeting HER2, trastuzumab and pertuzumab, combined with PLD and cyclophosphamide, will not only increase the pCR rate but also cause less cardiotoxicity for participants with residual cancer via core biopsy or non-clinical CR after receiving taxanes plus trastuzumab and pertuzumab or taxanes plus trastuzumab. The investigators also showed that ctDNA served as the surrogate prognostic marker for participants with HER2-positive EBC who received neoadjuvant trastuzumab-based regimens.
In this study, the investigators will explore whether the combination of PLD (Lipo-Dox®, Liposomal Doxorubicin Injection), cyclophosphamide, trastuzumab, and pertuzumab can increase the pCR rate of participants with HER2-positive EBC if they have residual cancers (core biopsy, non-clinical CR, or positive ctDNA) after receiving a trastuzumab and taxanes-based NAT regimen. In addition, the cardiac safety, adverse effects, and clearance of ctDNA will be explored for these patients. The investigators further assess the feasibility of VAB (before operation) in these participants who achieved negative ctDNA after receiving Lipo-Dox® plus cyclophosphamide, trastuzumab, and pertuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients | Experimental | Drug: Lipo-Dox®, Drug: Cyclophosphamide, Drug: Trastuzumab (Herceptin), Drug: Pertuzumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Diagnosis: HER2-positive Primary Invasive Breast Cancer
- Histologically confirmed invasive breast carcinoma
- HER2-positive breast carcinoma
- Clinical stage at presentation: T1-4, N0-3, M0 (T1N0M0 tumors will not be eligible)
- Patients must be willing to receive preoperative systemic chemotherapy with taxanes and HER-2-targeting treatment for at least 4 to 6 cycles.
Key exclusion criteria (11 listed)
- Stage IV (metastatic) breast cancer.
- History of any prior (ipsilateral- or contralateral) breast cancer except lobular carcinoma in situ.
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.
- Patients for whom radiotherapy would be recommended for breast cancer treatment, but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation).
- Current NCI common terminology criteria for adverse events (CTCAE) (Version 4.0): Grade ≥ 2 peripheral neuropathy.
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 |
|---|---|---|
| Lipo-Dox®Lipo-Dox®: 37.5 mg/m² on D1; every 21 days is one cycle, for a total of 4 cycles. | Drug | Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients |
| CyclophosphamideCyclophosphamide 600 mg/m² on D1, ; every 21 days is one cycle, for a total of 4 cycles. | Drug | Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients |
| Trastuzumab (Herceptin)Trastuzumab 6 mg/kg on D2; every 21 days is one cycle, for a total of 4 cycles. | Drug | Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients |
| PertuzumabPertuzumab 420 mg on D2; every 21 days is one cycle, for a total of 4 cycles. | Drug | Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for HER2-positive Breast Cancer Patients |
Primary outcome
Pathological complete remission rate (pCR)
Time frame: From enrollment to the end of operation.
Assessment of pathological specimens to determine when no cancer cells are detected in tissue samples (breast and lymph nodes) removed during surgery following preoperative treatment, such as chemotherapy.
4 secondary outcomes
Number of participants with Lipodox-containing regimen-related adverse events of cardiac function as assessed by CTCAE v4.0
Time frame: From enrollment, before and after completion of Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab, and 12 months after operation.
Clearance rate of circulating tumor DNA [ctDNA]
Time frame: From enrollment, completion of TH or THP regimens, completion of Lipodox plus cyclophosphamide, trastuzumab, and pertuzumab, and at the end of operation.
Number of participants with treatment with Lipo-Dox®-containing regimen-related adverse events as assessed by CTCAE v4.0.
Time frame: From starting a Lipo-Dox®-containing regimen to the end of treatment at 4 weeks.
Percentage of patients with complete removal of lesion via vacuum-assisted biopsy
Time frame: After completion of neoadjuvant chemotherapy regimens.
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 4 May 2026.
- Background: 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.
- Background: PubMed 34014249van der Voort A, van Ramshorst MS, van Werkhoven ED, Mandjes IA, Kemper I, Vulink AJ, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS. Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 Randomized, Phase 3 Trial. JAMA Oncol. 2021 Jul 1;7(7):978-984. doi: 10.1001/jamaoncol.2021.1371.
- Background: PubMed 39033747Tseng LM, Chen FM, Chen ST, Cheng FT, Chao TY, Dai MS, Kao WY, Yeh MH, Chen DR, Liu LC, Wang HC, Chang HT, Wang BW, Yu JC, Chen SC, Liao GS, Hou MF. Comparison of the Efficacy, Safety, and Quality of Life of Pegylated Liposomal Doxorubicin-Cyclophosphamide versus Epirubicin-Cyclophosphamide in Patients with Early-Stage HER2-Negative Breast Cancer: A Prospective, Randomized, Multicenter, Phase II Study. Oncol Res Treat. 2024;47(10):484-495. doi: 10.1159/000540369. Epub 2024 Jul 19.
- Results publication: PubMed 41543393Lin PH, Tsai LW, Lo C, Kuo SH, Ni CC, Yu CH, Huang CS. ctDNA Detected after Neoadjuvant Therapy for HER2-Positive Breast Cancer Is Associated with Inferior Outcomes and May Inform Adjuvant Therapy. Cancer Res Commun. 2026 Jan 1;6(1):105-114. doi: 10.1158/2767-9764.CRC-24-0234.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Chiun-Sheng Huang, M.D.,Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipo-Dox®, Cyclophosphamide and Trastuzumab (Herceptin) in people with HER-2 Positive Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 27 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 4 May 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 Taiwan. 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 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 Sung-Hsin Kuo, M.D.,Ph.D. (+886-972651671, shkuo101@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission rate (pCR) (time frame: From enrollment to the end of operation.). 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 NCT07565324, which also lists 4 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 4 May 2026.