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 3 Interventional 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.
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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 out Distant 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.

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About This Trial
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…
Trial Locations
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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…
Contacts

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