Breast CancerPhase 4NCT04182568
Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer
A Phase 4 study testing nab-paclitaxel followed by anthracycline and cyclophosphamide and Docetaxel followed by anthracycline and cyclophosphamide in people with Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nab-paclitaxel followed by anthracycline and cyclophosphamide and Docetaxel followed by anthracycline and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2019to 21 Aug 2022
- Phase
- Phase 4
- 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
- 1) age: 18-70 years old, female;
- 2) patients with primary breast cancer, T2 or above, diagnosed by histopathology;
- 3) HR was positive and HER-2 was negative by IHC;
- 4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm;
- 5) ECoG physical fitness score 0-1;
- 6) LVEF≥55%；
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- 7) bone marrow function: neutrophil ≥ 1.5 × 109 / L, platelet ≥ 100 × 109 / L, hemoglobin ≥ 90g / L;
- 8) liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5 times the upper limit of normal value, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal value;
- 9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent
Who cannot join
- 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- 2) patients with stage IV metastasis at the initial diagnosis;
- 2) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);
- 3) patients with serious systemic infection or other serious diseases;
- 4) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;
- 5) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma;
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- 6) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;
- 7) participated in other experimental studies within 30 days before the administration of the first study drug;
- 8) patients not suitable for the study were judged by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Juliang Zhang, Prof, 029-8477527, vascularzhang@163.com
About this study
This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.
- Conditions
- Breast Cancer
- Being tested
- nab-paclitaxel followed by anthracycline and cyclophosphamide, Docetaxel followed by anthracycline and cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxel followed by anthracycline and cyclophosphamideDrug
nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide
Docetaxel followed by anthracycline and cyclophosphamideDrug
Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel | Experimental | Not described Receives: Drug: nab-paclitaxel followed by anthracycline and cyclophosphamide |
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel followed by anthracycline and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
RCB
Residual tumor load
Measured: 2 years
Secondary outcomes (1)
pCR
Complete remission of Pathology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start21 Aug 2019
- Primary completion21 Aug 2021 (estimated)
- Study completion21 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182568
- Sponsor's protocol ID
- KY20192081-F-1
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer
- ClinicalTrials.gov ID
- NCT04182568
- Acronym / sponsor ID
- KY20192081-F-1
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 21 Aug 2021 (estimated)
- Study completion
- 21 Aug 2022 (estimated)
- First posted
- 2 Dec 2019 (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.
This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel | Experimental | Drug: nab-paclitaxel followed by anthracycline and cyclophosphamide |
| Docetaxel | Active comparator | Drug: Docetaxel followed by anthracycline and cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) age: 18-70 years old, female;
- 2) patients with primary breast cancer, T2 or above, diagnosed by histopathology;
- 3) HR was positive and HER-2 was negative by IHC;
- 4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm;
- 5) ECoG physical fitness score 0-1;
Key exclusion criteria (9 listed)
- 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- 2) patients with stage IV metastasis at the initial diagnosis;
- 2) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);
- 3) patients with serious systemic infection or other serious diseases;
- 4) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;
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 |
|---|---|---|
| nab-paclitaxel followed by anthracycline and cyclophosphamidenab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide | Drug | nab-paclitaxel |
| Docetaxel followed by anthracycline and cyclophosphamideDocetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide | Drug | Docetaxel |
Primary outcome
RCB
Time frame: 2 years
Residual tumor load
1 secondary outcome
pCR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nab-paclitaxel followed by anthracycline and cyclophosphamide and Docetaxel followed by anthracycline and cyclophosphamide in people with Breast Cancer, run by Xijing Hospital 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 9 inclusion and 9 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 2 Dec 2019. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Juliang Zhang, Prof (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RCB (time frame: 2 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 2 Dec 2019.