Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer

NCT05189067 | Unknown Phase 2

• 1 other identifier: 2021-0170
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Among women with stage I HER2-positive breast cancer, adjuvant weekly paclitaxel plus trastuzumab (PH, qw×12) is one of the standard therapies. However, it is quite inconvenient for patients to received weekly treatment for 12 weeks, which also increased the patients' and social economic burdens. In our study, a prospective, randomized, open-label, single-center clinical study was conducted to compare the efficacy and safety of adjuvant docetaxel plus trastuzumab (TH, q3w×4) and the classic regimen (PH, qw×12) in stage I HER2-positive breast cancer in Chinese population.

Conditions

HER2-positive Breast Cancer; Adjuvant Therapy

Keywords

Docetaxel; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• disease free survival

  Evaluate disease free survival (DFS) in patients with stage I HER2-positive breast cancer treated with adjuvant trastuzumab and docetaxel.

  Time of Surgery up to 5 years

Secondary Outcomes (2)

• overall survival

  Time of Surgery up to 5 years

• incidence of grade III/IV neurotoxicity

  First Dose of chemotherapy up to 12 months.

Study Arms (2)

paclitaxel + trastuzumab

ACTIVE COMPARATOR

paclitaxel × 12, every week a cycle, trastuzumab × 4, every 3 weeks a cycle; followed by trastuzumab, every 3 weeks a cycle for 9 months. Paclitaxel i.v. 80mg/m2, trastuzumab i.v. loading dose of 8 mg/kg, followed by 6mg/kg

Drug: Paclitaxel; Drug: Trastuzumab

docetaxel + trastuzumab

EXPERIMENTAL

(docetaxel + trastuzumab) × 4, every 3 weeks a cycle; followed by trastuzumab, every 3 weeks a cycle for 9 months. Docetaxel i.v. 100mg/m2, trastuzumab i.v. loading dose of 8 mg/kg, followed by 6mg/kg

Drug: Trastuzumab; Drug: Docetaxel

Interventions

Paclitaxel DRUG

i.v. 80mg/m\^2

Also known as: P

paclitaxel + trastuzumab

Trastuzumab DRUG

i.v. loading dose of 8 mg/kg, followed by 6mg/kg

Also known as: H

docetaxel + trastuzumab; paclitaxel + trastuzumab

Docetaxel DRUG

i.v. 100mg/m2

Also known as: T

docetaxel + trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18 - 70 years old;
• The histopathological confirm of invasive breast cancer;
• HER-2 positive: immuno-histochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) confirmed amplification of erbb2 gene;
• Tumor must be ≤ 2cm in greatest dimension, negative axillary lymph node or with micrometastasis (axillary nodes with tumor clusters ≤ 0.2cm);
• No more than 90 days from the patient's most recent breast surgery for this breast cancer;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
• Adequate bone marrow function: neutrophil ≥ 1500/mm\^3, hemoglobin ≥ 9 g/dl, and platelets ≥ 100,000/mm\^3;
• Adequate liver and renal function: creatinine ≤ 1.5 folds of the upper limit of normal value; aspartate aminotransferase and alanine aminotransferase ≤ 1.5 folds of the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2 folds of the upper limit of normal value for patient with Gilbert 's syndrome;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• Willing and able to sign informed consent.

You may not qualify if:

• Any of the following due to teratogenic potential of chemotherapy: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception;
• Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes;
• History of prior chemotherapy in the past 5 years;
• History of prior trastuzumab therapy;
• Patients with a history of previous invasive breast cancer;
• Active, unresolved infection;
• Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent;
• Can not tolerate or be allergic to chemotherapy, anti-HER-2 therapy or pharmaceutical materials such as benzyl alcohol;
• ≥ grade 2 neuropathy;
• The antibody of hepatitis C virus, HIV or Treponema pallidum positive; HBsAg positive and hepatitis B virus DNA in peripheral blood ≥ 10\^3 copy/mL；
• Enrollment on other Investigational studies within 30 days;
• Not allowed by the investigators.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Trastuzumab; Protons; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Tao Pan

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Pan

CONTACT

571-86993267; 2311318@zju.edu.cn

Kaimin Hu

CONTACT

571-86993267; hukmbdn@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 12, 2022
• Study Start: January 31, 2022
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: January 12, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)