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Trial record 88 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03500380
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen

Brief Summary:
This is a Phase II, randomized, multicenter, 2-arm, open-label clinical trial designed to compare the safety and efficacy of RC48-ADC with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Diseases Capecitabine HER2-positive Breast Cancer HER2 Positive Breast Carcinoma Drug: RC48-ADC Drug: Lapatinib Drug: Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase II Study of the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: RC48-ADC
Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Drug: RC48-ADC
RC48-ADC 2.0 mg/kg IV every 14 days
Other Name: RC48

Active Comparator: Lapatinib + Capecitabine
Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Drug: Lapatinib
Lapatinib 1250 mg orally once daily during each 21-day cycle.

Drug: Capecitabine
Capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle.




Primary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by an IRC [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Tumor response was assessed by an IRC according to RECIST v1.1.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by Investigator [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1.

  2. Objective Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

  3. Duration of Objective Response (DOR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.

  4. Clinical Benefit Rate (CBR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart.

  5. Time to Treatment Failure [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.

  6. Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 48 months ]
    OS was defined as the time from the date of randomization to the date of death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • Age ≥ 18 years and ≤ 70 years.
  • Predicted survival ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  • Adequate organ function, evidenced by the following laboratory results:

Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1500 cells/mm3 Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5× ULN AST, ALT, and ALP ≤ 2.5× ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1╳ULN or creatinine clearance≥ 60ml/min (Cockcroft-Gault equation) or 24-hour urine creatinine clearance≥ 60ml/min.

Cardiac ejection fraction ≥ 50 %.

  • Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer or MBC.
  • HER2-positive (defined as IHC 3+ or gene-amplified by FISH).
  • Prior treatment for breast cancer in the neoadjuvant, adjuvant, unresectable, locally advanced, or metastatic setting must include taxane, alone or in combination with another agent.
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include trastuzumab, alone or in combination with another agent.
  • Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer, defined by the investigator: Progression must occur during or after most recent treatment for locally advanced/MBC or within 6 months after completing adjuvant therapy.
  • Prior treatment for breast cancer in the locally advanced, or metastatic setting must include 1-2 lines of systemic chemotherapy.
  • Measurable disease according to RECIST 1.1.

Exclusion Criteria:

  • Current severe, uncontrolled systemic disease (e.g., clinically significant diabetes, hypertension, pulmonary disease).
  • Currently known active infection with HIV or tuberculosis.
  • Has known active liver disease ( e.g., Hepatitis B virus/ Hepatitis C virus or liver cirrhosis).
  • Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis.
  • History of treatment with other investigational drug within 4 weeks of planned start of trial treatment.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has a history of severe hypersensitivity reaction to study drug.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
  • known central nervous system metastases.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia.
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment except hormone therapy, which could be given up to 7 days.
  • History of receiving any Chinese drug within 7 days prior to trial treatment.
  • History of receiving any HER2-target drug.
  • History of receiving capecitabine within 6 months prior to trial treatment or intolerable to capecitabine.
  • Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency.
  • History of receiving t-dm1.
  • History of radiation therapy within 14 days of trial treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500380


Contacts
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Contact: Jianmin Fang +8610-58075763 jianminfang@hotmail.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shengyang, Liaoning, China
Contact: Yuee teng         
Liaoning Cancer Hospital & Institute Recruiting
Shenyang, Liaoning, China
Contact: Tao sun         
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Qiang Sun         
Peking University People's Hospital Recruiting
Beijing, China
Contact: Shu Wang         
The First Hospital of Jilin University Recruiting
Changchun, China
Contact: Zhimin Fan         
Hunan Cancer Hospital Recruiting
Changsha, China
Contact: Quchang Ouyang         
Affiliated Hospital of Chengde Medical University Recruiting
Chengde, China
Contact: Qingshan Li         
Sichuan Cancer Hospital Recruiting
Chengdu, China
Contact: Hui Li         
West China Hospital Recruiting
Chengdu, China
Contact: Jing Jing         
The Second Hospital of Dalian Medical University Recruiting
Dalian, China
Contact: Yang Zhang         
Fujian Cancer Hospital Recruiting
Fuzhou, China
Contact: Jian Liu         
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, China
Contact: Herui Yao         
The Affiliated Tumor Hospital of Guangzhou Medical University Recruiting
Guangzhou, China
Contact: Hongsheng Li         
Guizhou Cancer Hospital Recruiting
Guiyang, China
Contact: Li Ran         
The First Affiliated Hospital of Medical School of Zhejiang University Recruiting
Hangzhou, China
Contact: Peifen Fu         
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, China
Contact: Yongchuan Deng         
Zhejiang Cancer Hospital Recruiting
Hangzhou, China
Contact: Xiaojia Wang         
Harbin Medical University Cancer Hospital Recruiting
Harbin, China
Contact: Qingyuan Zhang         
Anhui Cancer Hospital Recruiting
Hefei, China
Contact: Changlu Hu         
Anhui Province Hospital Recruiting
Hefei, China
Contact: Yueyin Pan         
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, China
Contact: Kangsheng Gu         
Qilu Hospital of Shandong University Recruiting
Jinan, China
Contact: Xiuwen Wang         
Shandong Cancer Hospital Recruiting
Jinan, China
Contact: Yongsheng Wang         
Linyi Cancer Hospital Recruiting
Linyi, China
Contact: Jingfen Wang         
The First Affiliated Hospital of Henan University of Science & Technology Recruiting
Luoyang, China
Contact: Xinshuai Wang         
Jiangxi Cancer Hospital Recruiting
Nanchang, China
Contact: Yudong Wu         
Jiangsu Cancer Hospital Recruiting
Nanjing, China
Contact: Jifeng Feng         
Jiangsu Province Hospital Recruiting
Nanjing, China
Contact: Yongmei Yin         
The Affiliated Tumor Hospital of Guangxi Medical University Recruiting
Nanning, China
Contact: Weimin Xie         
Yunnan Cancer Hospital Recruiting
Nanning, China
Contact: Dequan Liu         
Hospital of Qingdao University Recruiting
Qingdao, China
Contact: Haibo Wang         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Zhimin Shao         
The Fourth Hospital of Hebei Medical University Recruiting
Shijiazhuang, China
Contact: Yunjiang Liu         
Hubei Cancer Hospital Recruiting
Wuhan, China
Contact: Xinhong Wu         
Wuhan Union Hospital Recruiting
Wuhan, China
Contact: Jing Cheng         
The First Affiliated Hospital of the Fourth Military University of P.L.A. Recruiting
Xi'an, China
Contact: Yan Xue         
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, China
Contact: Jin Yang         
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, China
Contact: Zhengqiu Zhu         
Xuzhou Central Hospital Recruiting
Xuzhou, China
Contact: Yong Liu         
Yantai Yuhuangding Hospital Recruiting
Yantai, China
Contact: Liangming Zhang         
Henan Cancer Hospital Recruiting
Zhengzhou, China
Contact: Min Yan         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, China
Contact: Yuanting Gu         
Sponsors and Collaborators
RemeGen

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT03500380     History of Changes
Other Study ID Numbers: RC48-C006
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lapatinib
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors