Breast CancerNCT05287308
Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
A study testing doxorubicin, epirubicin and pirarubicin in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer. 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?
- doxorubicin, epirubicin and pirarubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 patients aged from 18 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
- AC-T adjuvant chemotherapy is planned after breast cancer surgery;
- Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence [such as high Ki67 expression (≥20%), T > 2 cm, age < 35 years, lymphovascular invasion, grade 3 histology]; 2) HR negative with positive lymph node or T > 2 cm;
- LVEF ≥ 50%;
- Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Who cannot join
- In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
- Participants who have received prior any systematic treatment for breast cancer;
- Participants with bilateral invasive breast cancer;
- Breast cancer with distant metastasis;
- Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;
- Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes;
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- Previous or current existence of other malignant tumors other than breast cancer;
- Severe liver and kidney dysfunction;
- The presence of any myelodysplastic and other hematopoietic disorders;
- Participants who are known to be allergic to the active or other components of the study treatment;
- Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
- Participants who were judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- doxorubicin, epirubicin, pirarubicin, cyclophosphamide, albumin-bound paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicinDrug
doxorubicin 50~60mg/m2, i.v., d1, q3w or q2w.
epirubicinDrug
epirubicin 80~100mg/m2, i.v., d1, q3w or q2w.
pirarubicinDrug
pirarubicin 40~50mg/m2, i.v., d1, q3w or q2w.
cyclophosphamideDrug
cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
albumin-bound paclitaxelDrug
albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
paclitaxelDrug
paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
docetaxelDrug
docetaxel 80~100mg/m2, i.v., d1, q3w.
| Study group | Role | What they receive |
|---|---|---|
| AC followed by albumin-bound paclitaxel | Experimental | A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles. Receives: Drug: doxorubicin; Drug: epirubicin; Drug: pirarubicin; Drug: cyclophosphamide; Drug: albumin-bound paclitaxel |
| AC followed by taxanes | Active comparator | A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles. Receives: Drug: doxorubicin; Drug: epirubicin; Drug: pirarubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year invasive disease-free survival (IDFS) rate
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years.
Measured: up to 60 months
Secondary outcomes (4)
IDFS
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause.
Measured: up to 60 months
overall survival (OS)
OS was defined as the time from enrollment assignment to death as a result of any cause.
Measured: up to 60 months
3-year invasive disease-free survival (IDFS) rate
3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.
Measured: up to 36 months
Incidence and severity of adverse events
Adverse events as assessed by NCI-CTCAE V5.0
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287308
- Sponsor's protocol ID
- LQ009
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
- ClinicalTrials.gov ID
- NCT05287308
- Acronym / sponsor ID
- LQ009
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Mar 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.
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC followed by albumin-bound paclitaxel | Experimental | Drug: doxorubicin, Drug: epirubicin, Drug: pirarubicin, Drug: cyclophosphamide, Drug: albumin-bound paclitaxelA (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles. |
| AC followed by taxanes | Active comparator | Drug: doxorubicin, Drug: epirubicin, Drug: pirarubicin, Drug: cyclophosphamide, Drug: paclitaxel, Drug: docetaxelA (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged from 18 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
- AC-T adjuvant chemotherapy is planned after breast cancer surgery;
Key exclusion criteria (12 listed)
- In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
- Participants who have received prior any systematic treatment for breast cancer;
- Participants with bilateral invasive breast cancer;
- Breast cancer with distant metastasis;
- Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;
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 |
|---|---|---|
| doxorubicindoxorubicin 50~60mg/m2, i.v., d1, q3w or q2w. | Drug | AC followed by albumin-bound paclitaxel, AC followed by taxanes |
| epirubicinepirubicin 80~100mg/m2, i.v., d1, q3w or q2w. | Drug | AC followed by albumin-bound paclitaxel, AC followed by taxanes |
| pirarubicinpirarubicin 40~50mg/m2, i.v., d1, q3w or q2w. | Drug | AC followed by albumin-bound paclitaxel, AC followed by taxanes |
| cyclophosphamidecyclophosphamide 600mg/m2, i.v., d1, q3w or q2w. | Drug | AC followed by albumin-bound paclitaxel, AC followed by taxanes |
| albumin-bound paclitaxelalbumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw. | Drug | AC followed by albumin-bound paclitaxel |
| paclitaxelpaclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw. | Drug | AC followed by taxanes |
| docetaxeldocetaxel 80~100mg/m2, i.v., d1, q3w. | Drug | AC followed by taxanes |
Primary outcome
5-year invasive disease-free survival (IDFS) rate
Time frame: up to 60 months
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years.
4 secondary outcomes
IDFS
Time frame: up to 60 months
overall survival (OS)
Time frame: up to 60 months
3-year invasive disease-free survival (IDFS) rate
Time frame: up to 36 months
Incidence and severity of adverse events
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxorubicin, epirubicin and pirarubicin in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 31 Mar 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiao Li, MD (86-10-87788120, liqiaopumc@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year invasive disease-free survival (IDFS) rate (time frame: up to 60 months). 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 31 Mar 2022.