HER2-positive Metastatic Breast CancerPhase 3NCT04385563

A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.

A Phase 3 study testing TQ-B211, Herceptin® and docetaxel in people with HER2-positive Metastatic Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the efficacy,safety and immunogenicity of TQ-B211 plus docetaxel versus Herceptin® plus docetaxel in Patients with HER2-positive metastatic breast cancer.Trastuzumab plus docetaxel was chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC… Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: HER2-positive Metastatic Breast Cancer
What is being tested?: TQ-B211, Herceptin® and docetaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 338 participants
Where: 2 sitesChina
Study dates: 11 Nov 2018to Oct 2021
Phase: Phase 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 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to give written informed consent.
Age：≥18 and ≤75,female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Life expectancy of at least 12 weeks.
Histologically confirmed diagnosis as her2-positive metastatic or locally recurrent breast cancer that cannot be treated with radical surgery or radiotherapy.
No prior systematical chemotherapy, biotherapy or molecule-targeted therapy for metastatic breast cance.
Patients must have a measurable disease according to RECIST v. 1.1 28 days before randomization. (Disease in brain or bone will not be included)

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Left ventricular ejection fraction (LVEF) ≥50 percent (%)
Blood routine examination should meet the following conditions: Absolute neutrophil count (ANC)≥1.5×109/L Platelets ≥100 x 109/L Hemoglobin ≥90 g/L hemameba≥3.0×109/L )
Liver function should meet the following conditions:
Total bilirubin ≤1.5x Upper Limit of Normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x ULN if no liver involvement or ≤5x ULN with liver involvement.
-Kidney function should meet the following conditions: Cr (creatinine) ≤1.5x ULN or Ccr (creatinine clearance rate) ≥50 mL/min.
The coagulation function should meet the following conditions: International normalized ratio（INR）≤1.5；Activated partial thromboplastin time or partial thromboplastin time ≤1.5×ULN
Female who meet the following criteria can participate in the study:
No childbearing potential； Female with childbearing potential: negative pregnancy test within 7 days before the first administration of the investigational drug; patients are not breastfeeding; Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment.

Who cannot join

Not eligible for docetaxel combination therapy.
Endocrine therapy within 2 weeks before randomization.
Patients had received neoadjuvant or adjuvant therapy with herceptin 12 months before randomization.
Patients had received neoadjuvant/adjuvant drugs containing other anthracycline or taxol 6 months before randomization.
Patients had used Chinese patent medicine or Chinese herbal medicine with anti-cancer activity 2 weeks before randomization.
Brain metastases with symptom/untreated brain metastases/other central nervous system(CNS) metastases. Treated CNS metastases remain stable for at least 4 weeks before the study, and no evidence of cerebral edema, no sign for glucosinolates or anticonvulsants treatments.

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Patients with a previous malignancy within the past 5 years (other than curatively treated in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma).
Hepatitis virus C(HCV) positive, HIV positive, syphilis positive, or HBsAg positive and Hepatitis virus B(HBV) DNA titer in peripheral blood is beyond the normal range.
Patients had received major surgical procedures (including open chest biopsy) major trauma (e.g. fracture) within 4 weeks before randomization, and there are unhealed wounds, ulcers or fractures at the time of screening or major surgery is expected during the study
Patients have a history of hypertensive encephalopathy or a hypertension or an uncontrolled hypertension ( systolic blood pressure >150mmHg or diastolic blood pressure >100mmHg with antihypertensive drugs)
Patients had a history of myocardial infarction 6 months before randomization; medical history of congestive heart failure in New York heart association classification (NYHA)≥ grade II,and a severe arrhythmia that cannot be controlled by drugs（atrial fibrillation and paroxysmal supraventricular tachycardia are excluded）;LVEF had previously declined to less than 50% during or after new trastuzumab adjuvant or adjuvant therapy.
Allergies to herceptin ®/ TQ-B211 or the chemotherapies involved in this trial and their excipients.
History hypersensitivity to any study drug .
Patients had participated in clinical trials of other antitumor drugs 4 weeks before randomization .
Not eligible to join the study judged by investigators.

Trial locations and contacts

2 sites in 1 country.

Xi chun Hu, Doctor contact

021-64175590-85007

xichun2009@hotmail.com

China2 sites, 2 recruiting

Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qing yuan Zhang, Doctor, 0451-86298070, 13313612989@163.com
Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200123
Xi chun Hu, Doctor
Recruiting

Other trials in China

About this study

Official title: A Phase III,Randomized,Multicenter,Double-blind Clinical Trail to Evaluate the Efficacy,Safety and Immunogenicity of the Combination of TQ-B211 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First-line Treatment in Patients With HER2-positive MBC.

Conditions: HER2-positive Metastatic Breast Cancer
Being tested: TQ-B211, Herceptin®, docetaxel

What participants receive

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

TQ-B211Drug
Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
Herceptin®Drug
Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
docetaxelDrug
Participants will receive docetaxel 75 milligrams/square meter (mg/m^2) iv.on day 2 in Cycle 1 followed by 75mg/m^2 iv.on day 1 in Cycles 2 to 8.

Study groups in NCT04385563
Study group	Role	What they receive
TQ-B211 + docetaxel	Experimental	Participants will be administered TQ-B211 plus docetaxel once every three weeks(Q3W) in cycles up to cycle 8. Receives: Drug: TQ-B211; Drug: docetaxel
Herceptin®+docetaxel	Active comparator	Participants will be administered Herceptin® plus docetaxel Q3W in cycles up to cycle 8. Receives: Drug: Herceptin®; Drug: docetaxel

What is being measured

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

Objective response rate (ORR)
ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments.
Measured: Baseline up to week 24（Baseline up to 8 cycles）

Secondary outcomes (4)

Duration of Response (DOR)
DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study.
Measured: up to week 120
Progression-free survival (PFS)
PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments.
Measured: up to week 120
Disease control rate(DCR)
DCR was defined as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
Measured: up to week 120
Overall survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Measured: up to week 120

Timeline

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

11 Nov 2018Oct 2021

First posted13 May 2020
Study start11 Nov 2018
Primary completionFeb 2021 (estimated)
Study completionOct 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2-positive Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 338 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04385563
Sponsor's protocol ID: TQB211-III-01
Status last verified: May 2020
First submitted: 9 May 2020
Last updated: 13 May 2020
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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III,Randomized,Multicenter,Double-blind Clinical Trail to Evaluate the Efficacy,Safety and Immunogenicity of the Combination of TQ-B211 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First-line Treatment in Patients With HER2-positive MBC.
ClinicalTrials.gov ID: NCT04385563
Acronym / sponsor ID: TQB211-III-01
Conditions: HER2-positive Metastatic Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 338 participants (estimated)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Nov 2018 (actual)
Primary completion: Feb 2021 (estimated)
Study completion: Oct 2021 (estimated)
First posted: 13 May 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TQ-B211 + docetaxel	Experimental	Drug: TQ-B211, Drug: docetaxelParticipants will be administered TQ-B211 plus docetaxel once every three weeks(Q3W) in cycles up to cycle 8.
Herceptin®+docetaxel	Active comparator	Drug: Herceptin®, Drug: docetaxelParticipants will be administered Herceptin® plus docetaxel Q3W in cycles up to cycle 8.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Ability to give written informed consent.
Age：≥18 and ≤75,female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Life expectancy of at least 12 weeks.
Histologically confirmed diagnosis as her2-positive metastatic or locally recurrent breast cancer that cannot be treated with radical surgery or radiotherapy.
No prior systematical chemotherapy, biotherapy or molecule-targeted therapy for metastatic breast cance.

Key exclusion criteria (15 listed)

Not eligible for docetaxel combination therapy.
Endocrine therapy within 2 weeks before randomization.
Patients had received neoadjuvant or adjuvant therapy with herceptin 12 months before randomization.
Patients had received neoadjuvant/adjuvant drugs containing other anthracycline or taxol 6 months before randomization.
Patients had used Chinese patent medicine or Chinese herbal medicine with anti-cancer activity 2 weeks before randomization.

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
TQ-B211Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.	Drug	TQ-B211 + docetaxel
Herceptin®Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.	Drug	Herceptin®+docetaxel
docetaxelParticipants will receive docetaxel 75 milligrams/square meter (mg/m^2) iv.on day 2 in Cycle 1 followed by 75mg/m^2 iv.on day 1 in Cycles 2 to 8.	Drug	Herceptin®+docetaxel, TQ-B211 + docetaxel

Primary outcome

Objective response rate (ORR)
Time frame: Baseline up to week 24（Baseline up to 8 cycles）
ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments.

4 secondary outcomes

Duration of Response (DOR)
Time frame: up to week 120
Progression-free survival (PFS)
Time frame: up to week 120
Disease control rate(DCR)
Time frame: up to week 120
Overall survival (OS)
Time frame: up to week 120

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.

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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.

Xi chun Hu, Doctor contact

021-64175590-85007

xichun2009@hotmail.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQ-B211, Herceptin® and docetaxel in people with HER2-positive Metastatic Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 14 inclusion and 15 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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 Xi chun Hu, Doctor (021-64175590-85007, xichun2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Baseline up to week 24（Baseline up to 8 cycles）). 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 NCT04385563.

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 13 May 2020.