Study Evaluating Hemay022 in Combination With Exemestane In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03308201|
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : June 19, 2018
The purposes of this study are to assess the safety, tolerability of combining Hemay022 with exemestane in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR( Optimal Tolerated Regimen). The secondary purpose of this study is to assess the pharmacokinetics and efficacy of combining Hemay022 with exemestane.
The study will be conducted in two parts. Part one, trial will be conducted in 15-24 subjects to determine safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. Part two, approximately 24 additional subjects with ER and HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Hemay022 Drug: exemestane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Evaluating Hemay022 in Combination With Exemestane In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Experimental: Hemay022 and Exemestane
Part one: Hemay022 in combination with exemestane will be taken orally once daily. Planned dose escalation of Hemay022 will be 200mg, 300mg,400mg or 500mg daily for 28 days.
Part two: Hemay022 in combination with exemestane will be taken in OTR dose until disease progression, intolerable toxicity or death.
Part one: Hemay022 tablets will be taken orally once daily in doses of 200mg, 300mg,400mg or 500mg for 28 days in combination with exemestane.
Part two: Hemay022 tablets will be taken in OTR dose group in combination with exemestane.
Part one and Part two: Exemestane will be taken in 25mg once daily.
- Number of participants with adverse events [ Time Frame: from baseline until 4 weeks after the study day ]
- Objective response rate (complete response rate + partial response rate) according to RECIST v1.1 [ Time Frame: At screening, every 8 weeks of treatment up to 18 months ]
- Clinical benefit rate defined as percentage of patients with stable disease (SD) ≥ 6 months/partial response (PR)/complete response (CR). according to RECIST v1.1 [ Time Frame: At screening, every 8 weeks of treatment up to 18 months ]
- Progression Free Survival defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria) [ Time Frame: 18 months after treatment initiation ]
- Observed maximum concentration of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
- Time of maximum concentration of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
- Area under the plasma concentration versus time curve of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
- Trough Plasma Concentrations of Hemay022 and exemestane [ Time Frame: pre-dose on day 14 ]
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): NCT03308201
|Contact: Huiping Lifirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Contact: Huiping Li|
|Principal Investigator:||Huiping Li||Beijing Cancer Hospital|