HER2-positive Breast CancerPhase 2/3NCT05189067
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
A Phase 2/3 study testing Paclitaxel, Trastuzumab and Docetaxel in people with HER2-positive Breast Cancer and Adjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Adjuvant Therapy
- What is being tested?
- Paclitaxel, Trastuzumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2022to 30 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Tao Pan, 057186993267, 2311318@zju.edu.cn
About this study
Official title: A Single-center, Prospective, Randomized Study of Adjuvant Paclitaxel and Trastuzumab Versus Docetaxel and Trastuzumab in Stage I HER2 Positive Breast Cancer
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.
Read the 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.
- Conditions
- HER2-positive Breast Cancer, Adjuvant Therapy
- Being tested
- Paclitaxel, Trastuzumab, Docetaxel
- Keywords
- Docetaxel, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called P
i.v. 80mg/m^2
TrastuzumabDrug
Also called H
i.v. loading dose of 8 mg/kg, followed by 6mg/kg
DocetaxelDrug
Also called T
i.v. 100mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Evaluate disease free survival (DFS) in patients with stage I HER2-positive breast cancer treated with adjuvant trastuzumab and docetaxel.
Measured: Time of Surgery up to 5 years
Secondary outcomes (2)
overall survival
Evaluate overall survival (OS) in patients with stage I HER2-positive breast cancer treated with adjuvant trastuzumab and docetaxel.
Measured: Time of Surgery up to 5 years
incidence of grade III/IV neurotoxicity
Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant docetaxel compared with paclitaxel.
Measured: First Dose of chemotherapy up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start31 Jan 2022 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Pan, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189067
- Sponsor's protocol ID
- 2021-0170
- Status last verified
- Nov 2021
- First submitted
- 6 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized Study of Adjuvant Paclitaxel and Trastuzumab Versus Docetaxel and Trastuzumab in Stage I HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05189067
- Acronym / sponsor ID
- 2021-0170
- Conditions
- HER2-positive Breast Cancer, Adjuvant Therapy
- Keywords
- Docetaxel, Paclitaxel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 Jan 2022 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Jan 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel + trastuzumab | Active comparator | Drug: Paclitaxel, Drug: Trastuzumabpaclitaxel × 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 |
| docetaxel + trastuzumab | Experimental | Drug: Trastuzumab, Drug: Docetaxel(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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| PaclitaxelAlso: Pi.v. 80mg/m^2 | Drug | paclitaxel + trastuzumab |
| TrastuzumabAlso: Hi.v. loading dose of 8 mg/kg, followed by 6mg/kg | Drug | docetaxel + trastuzumab, paclitaxel + trastuzumab |
| DocetaxelAlso: Ti.v. 100mg/m2 | Drug | docetaxel + trastuzumab |
Primary outcome
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.
2 secondary outcomes
overall survival
Time frame: Time of Surgery up to 5 years
incidence of grade III/IV neurotoxicity
Time frame: First Dose of chemotherapy up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tao Pan principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Paclitaxel, Trastuzumab and Docetaxel in people with HER2-positive Breast Cancer and Adjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Pan (571-86993267, 2311318@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: Time of Surgery up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.