Breast CancerNCT03017404

A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

A study testing Doxorubicin Hydrochloride Liposome Injection, Cyclophosphamide and docetaxel in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced 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 Hydrochloride Liposome Injection, Cyclophosphamide and docetaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: May 2015to Jul 2016
Phase: Interventional
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 patients newly diagnosed breast cancer≥18 and ≤70 years of age;
Karnofsky performance status≥70 and measurable or evaluable;
Stages Ⅲa-ⅢC;
Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
Adequate marrow function (WBC count> 4.0×10(9)/L, neutrophil> 2.0×10(9)/L, platelet count > 100×10(9)/L，hemoglobin > 90g/L );
AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase

Show all 11Show fewer

≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
Expected lifetime ≥ 12 months;
Pregnancy tests of reproductive age women is negative;
All patients provided written informed consent.

Who cannot join

Distant metastasis;
Severe heart failure (NYHA grade II or higher);
Active and uncontrolled severe infection;
Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
Pregnancy or breast feeding;
Other situations that investigators consider as contra-indication for this study

Trial locations and contacts

1 site in 1 country.

China1 site

Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050019

Other trials in China

About this study

Official title: A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer

Conditions: Breast Cancer
Being tested: Doxorubicin Hydrochloride Liposome Injection, Cyclophosphamide, docetaxel
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxorubicin Hydrochloride Liposome InjectionDrug
CyclophosphamideDrug
docetaxelDrug

Study groups in NCT03017404
Study group	Role	What they receive
treatment group:35 mg/m(2)	Experimental	Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy Receives: Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: docetaxel
treatment group:40 mg/m(2)	Experimental	Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy Receives: Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: docetaxel
treatment group:45 mg/m(2)	Experimental	Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy Receives: Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: docetaxel
treatment group:50 mg/m(2)	Experimental	Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy Receives: Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Cyclophosphamide; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

maximum tolerated dose
Measured: 4 cycles (each cycle is 21 days) of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Jul 2016

First posted11 Jan 2017 (estimated)
Study startMay 2015
Primary completionMay 2016
Study completionJul 2016

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 Hebei Medical University Fourth 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03017404
Sponsor's protocol ID: CSPC-DMS-BC-02
Status last verified: Jan 2017
First submitted: 9 Jan 2017
Last updated: 11 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer
ClinicalTrials.gov ID: NCT03017404
Acronym / sponsor ID: CSPC-DMS-BC-02
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Hebei Medical University Fourth HospitalUniversity, hospital or other
Study start: May 2015
Primary completion: May 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 11 Jan 2017 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
treatment group:35 mg/m(2)	Experimental	Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: docetaxelDoxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
treatment group:40 mg/m(2)	Experimental	Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: docetaxelDoxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
treatment group:45 mg/m(2)	Experimental	Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: docetaxelDoxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
treatment group:50 mg/m(2)	Experimental	Drug: Doxorubicin Hydrochloride Liposome Injection, Drug: Cyclophosphamide, Drug: docetaxelDoxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
Karnofsky performance status≥70 and measurable or evaluable;
Stages Ⅲa-ⅢC;
Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
Adequate marrow function (WBC count> 4.0×10(9)/L, neutrophil> 2.0×10(9)/L, platelet count > 100×10(9)/L，hemoglobin > 90g/L );

Key exclusion criteria (7 listed)

Distant metastasis;
Severe heart failure (NYHA grade II or higher);
Active and uncontrolled severe infection;
Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;

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
Doxorubicin Hydrochloride Liposome Injection	Drug	treatment group:35 mg/m(2), treatment group:40 mg/m(2), treatment group:45 mg/m(2), treatment group:50 mg/m(2)
Cyclophosphamide	Drug	treatment group:35 mg/m(2), treatment group:40 mg/m(2), treatment group:45 mg/m(2), treatment group:50 mg/m(2)
docetaxel	Drug	treatment group:35 mg/m(2), treatment group:40 mg/m(2), treatment group:45 mg/m(2), treatment group:50 mg/m(2)

Primary outcome

maximum tolerated dose
Time frame: 4 cycles (each cycle is 21 days) of chemotherapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Hydrochloride Liposome Injection, Cyclophosphamide and docetaxel in people with Breast Cancer, run by Hebei Medical University Fourth 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jan 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (time frame: 4 cycles (each cycle is 21 days) of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017404.

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 11 Jan 2017.