- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05189067
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
A Single-center, Prospective, Randomized Study of Adjuvant Paclitaxel and Trastuzumab Versus Docetaxel and Trastuzumab in Stage I HER2 Positive Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HER2-positive breast cancer accounts for about 20% of invasive breast cancers and was historically associated with poor clinical outcomes. Trastuzumab, a humanized monoclonal antibody that binds HER2, improved the outcomes for patients with HER2-positive breast cancer. Four phase 3 randomized trials (HERA, the North Central Cancer Treatment Group N9831, the National Surgical Adjuvant Breast and Bowel Project B-31 and BCIRG006) involving more than 8000 patients showed that when trastuzumab was administered in combination with or after chemotherapy, the risk of recurrence was decreased by approximately 50% and overall survival improved.
For patients with lymph node negative, early stage HER2-positive breast cancer, epirubicin/cyclophosphamide followed by docetaxel/trastuzumab (AC-TH) or docetaxel/carboplatin/trastuzumab (TCbH) adjuvant regimen is still widely used, although a smaller absolute benefit is expected. According to the long-term survival outcome of the Adjuvant Paclitaxel and Trastuzumab (APT) trial, patients with tumors measuring up to 3 cm in greatest dimension, negative axillary lymph node or with only micrometastasis, who received adjuvant paclitaxel 80mg/m2 weekly for 12 times plus 1 year trastuzumab, achieved a 3-year disease free survival (DFS) of 98.5%, 5-year DFS of 96.3%, 7-year DFS of 93.3%. The FDA compared the outcome of APT trial with external controls from previous clinical trials, both DFS and overall survival (OS) were similar.
However, weekly regimen is quite inconvenient for patients, which also increased the patients'and social economic burdens in China. Docetaxel, a newly developed taxoid anticancer agent, works a comparable way to paclitaxel. In the clinical trial E1199, early breast cancer patients receiving adjuvant adriamycin and cyclophosphamide (AC) followed by docetaxel every 3 weeks achieved similar outcomes with AC followed weekly paclitaxel. In our study, a prospective, randomized, open-label, single-center clinical study is 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Tao Pan
- Phone Number: 571-86993267
- Email: 2311318@zju.edu.cn
Study Contact Backup
- Name: Kaimin Hu
- Phone Number: 571-86993267
- Email: hukmbdn@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
-
Contact:
- Tao Pan
- Phone Number: 057186993267
- Email: 2311318@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Active cardiac disease: Any prior myocardial infarction (asymptomatic changes on EKG suggestive of old myocardial infarction is not an exclusion); Documented congestive heart failure (CHF); Current use of any therapy specifically for CHF; Current uncontrolled hypertension (diastolic >100 mmHg or systolic > 200 mmHg); Clinically significant pericardial effusion;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: paclitaxel + trastuzumab
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 |
i.v. 80mg/m^2
Other Names:
i.v.
loading dose of 8 mg/kg, followed by 6mg/kg
Other Names:
|
EXPERIMENTAL: docetaxel + trastuzumab
(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 |
i.v.
loading dose of 8 mg/kg, followed by 6mg/kg
Other Names:
i.v. 100mg/m2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease free survival
Time Frame: Time of Surgery up to 5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: Time of Surgery up to 5 years
|
Evaluate overall survival (OS) in patients with stage I HER2-positive breast cancer treated with adjuvant trastuzumab and docetaxel.
|
Time of Surgery up to 5 years
|
incidence of grade III/IV neurotoxicity
Time Frame: First Dose of chemotherapy up to 12 months.
|
Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant docetaxel compared with paclitaxel.
|
First Dose of chemotherapy up to 12 months.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tao Pan, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Docetaxel
- Paclitaxel
- Trastuzumab
Other Study ID Numbers
- 2021-0170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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