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Triple Negative Breast NeoplasmsPhase 2NCT03692689

Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer

A Phase 2 study testing SCT200 in people with Triple Negative Breast Neoplasms, run by Sinocelltech Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
SCT200
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 Jul 2018to 31 Dec 2019
Phase
Phase 2
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

  • Able to provide written informed consent and can understand and comply with the requirements of the study;
  • Women from 18 to 75 years old;
  • Life expectancy of longer than 3 months ( clinical assessment);
  • With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2).If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER,PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ \& fluorescent in situ hybridization (FISH)negative. If the ER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative.
  • Participants has received prior anthracyclines and/or taxanes in first-line therapy. Disease progressed after latest chemotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy.
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  • According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline.
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.
  • -Females: Post-menopausal, surgically sterile, non-pregnant and non-lactating.Women of childbearing potential must not be pregnant as assessed by a negative serum beta HCG test drawn upon admission to the hospital or up to 7 days prior to admission, and must agree to use adequate contraception (Oral contraceptives; intrauterine deviceshormonal; barrier method of birth control; abstinence) for the duration of study participation.and within 6 months after study.

Who cannot join

  • Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
  • Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis;
  • Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time less than 28 days,the subject is allowed to use it. Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.
  • Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer or carcinoma in situ of cervix;
  • Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
  • Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
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  • Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
  • Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
  • Patients treated with EPO, G-CSF or GM-CSF.
  • Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); Patients occurred myocardial infarction within 6 months.
  • According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.).
  • Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
  • Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
  • Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
  • Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
  • Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
  • Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
  • Patients have alcohol or drug addiction;
  • Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures;

Trial locations and contacts

1 site in 1 country.

qingyuan zhang, MD contact

0086-451-86298276

sy86298276@163.com

China1 site, 1 recruiting

  • Cancer Hospital Affiliated to Harbin Medical University

    Harbin, Heilongjiang, 150081

    qingyuan zhang, MD

    Recruiting

Other trials in China

About this study

Official title: Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer : a Phase Ⅱ, Open-label, Single-arm, Multicenter Study

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).

Read the detailed description

This open label,single-arm multicenter phase II study is designed to evaluate Objective Response Rate (ORR) in advanced triple receptor negative breast cancer treated with anti-EGFR monoclonal antibody SCT200.

Being tested
SCT200
Keywords
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasms by Site, Neoplasms, Epidermal growth factor receptor, EGFR, SCT200
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasms by Site, Neoplasms

What participants receive

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

  • SCT200Biological

    Recombinant Anti-EGFR Monoclonal Antibody（SCT200）

Study groups in NCT03692689
Study groupRoleWhat they receive
SCT200ExperimentalInitially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
Receives: Biological: SCT200

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

    Measured: 1 year

Secondary outcomes (6)

  1. Adverse events (AEs)

    AE are assessed according to NCI CTCAE v4.03.

    Measured: 1 year

  2. Progress Free Survival ( PFS)

    PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.

    Measured: 1 year

  3. Duration of response (DOR)

    DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.

    Measured: 1 year

  4. Disease control rate (DCR)

    The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.

    Measured: 1 year

  5. Time to Progression (TTP)

    TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.

    Measured: 1 year

  6. Overall survival (OS)

    OS is defined as time from first dose of SCT200 until the date of death from any cause.

    Measured: 1 year

Timeline

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

  1. First posted2 Oct 2018
  2. Study start20 Jul 2018
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692689
Sponsor's protocol ID
SCT200IITNBC
Status last verified
Mar 2018
First submitted
29 Sep 2018
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCT200 in people with Triple Negative Breast Neoplasms, run by Sinocelltech Ltd. 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 20 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 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 qingyuan zhang, MD (0086-451-86298276, sy86298276@163.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: 1 year). 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 NCT03692689.

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 Oct 2018.

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