Pegylated Liposomal Doxorubicin for HER-2 Positive Breast Cancer
Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
372 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Who this trial is looking for
This trial is looking for women aged 18 to 70 with HER-2 positive breast cancer who have not had previous treatment. Participants will receive specific combinations of chemotherapy drugs and will be monitored for their health and response to the treatment.
Are You a Good Fit for This Trial?
Rules you outDistant metastasisSevere cardiac diseaseSerious neurological disorders
You may be able to join if
I am a woman aged 18 to 70.
I have been diagnosed with invasive breast cancer.
I have HER-2 positive breast cancer.
My tumor is larger than 2 cm.
I have recently been diagnosed with lymph node metastasis.
I have a measurable disease.
I have good performance status.
I understand the study procedures and can give consent.
You may not be able to join if
I have breast cancer that has spread to other parts of my body.
I have multiple breast tumors in different areas.
I have had previous treatment for breast cancer.
I have serious heart problems.
I have severe neurological or psychiatric disorders.
I have a history of other cancers in the last 5 years.
I am pregnant or breastfeeding.
I do not want to use contraception during the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a multicenter, open label, non-inferiority, randomized controlled clinical study.
The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoa…
This is a multicenter, open label, non-inferiority, randomized controlled clinical study.
The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Female patients aged from 18 to 70 years old;
2. Histologically confirmed as invasive breast cancer and without previous treatment.;
3. HER-2 Positive (defined by IHC 3+ or ISH positive);
4. Tumor \> 2cm;
5. Biopsy pathology (FNAB or CNB) diagnosed regional lymph node metasta…
Inclusion Criteria:
1. Female patients aged from 18 to 70 years old;
2. Histologically confirmed as invasive breast cancer and without previous treatment.;
3. HER-2 Positive (defined by IHC 3+ or ISH positive);
4. Tumor \> 2cm;
5. Biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis within 28 days prior to randomization;
6. Participants must have at least one measurable disease according to RECIST 1.1.
7. Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive.
8. Operable breast cancer with cT2-cT4/cN1-cN3/cM0, according to the AJCC tumor staging manual (8th Edition).
9. The HR(ER and PR) status of the primary tumor and the expression level of Ki-67 are clear.
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
11. LVEF ≥ 55%;
12. Brain natriuretic peptide (BNP) (or N-terminal pro brain natriuretic peptide (NT proBNP)) and cardiac troponin assays were within normal values.
13. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and serum total bilirubin are all ≤2 ULN. Serum creatinine ≤ 1.5 ULN.
14. Bone marrow function: white blood cell counts ≥ 3.0x10\^9/L, absolute neutrophil counts (ANC) ≥ 1.5x10\^9/L, platelets ≥ 100x10\^9/L, hemoglobin ≥ 90g/L;
15. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Exclusion Criteria:
1. Breast cancer with distant metastasis;
2. Participants with multiple lesions (in different quadrants) or bilateral breast cancer;
3. Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, \>5 years must have passed from surgery until diagnosis of current breast cancer;
4. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1)High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2)Angina pectoris requiring anti-angina medication; 3)Clinically significant valvular heart disease; 4)ECG showing transmural myocardial infarction; 5)Uncontrolled hypertension (eg systolic blood pressure \> 180mm Hg or diastolic blood pressure \> 100mmHg); 6)Myocardial infarction; 7)Congestive heart failure;
5. Participants have the following serious illnesses or medical conditions, including but not limited: 1)History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2)Active uncontrolled infection; 3)Active peptic ulcer, unstable diabetes;
6. A history of other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin;
7. Treatment with any investigational drug within 28 days prior to randomization;
8. Participants who are known to be allergic to the active or other components of the study treatment or have contraindications for surgery;
9. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
10. Participants who were judged by the investigator to be unsuitable for this study.
Contacts
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