A Multi-cohort Phase II Study of HER2-positive and Triple-negative Breast Cancer Brain Metastases.
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|ClinicalTrials.gov Identifier: NCT04303988|
Recruitment Status : Unknown
Verified March 2020 by Fudan University.
Recruitment status was: Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Pyrotinib Drug: Temozolomide Injection Drug: SHR-1316 Drug: Bevacizumab Drug: Cisplatin/Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-arm, Single-center, Multi-cohort Phase II Clinical Study of HER2-positive and Triple-negative Breast Cancer Brain Metastases|
|Estimated Study Start Date :||March 30, 2020|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||January 30, 2022|
Experimental: Cohort HR+/HER2+
Hormone receptor negative, HER2 positive participants will receive Pyrotinib in combination with Temozolomide until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Other Name: SHR-1258
Drug: Temozolomide Injection
Other Name: Ainituo
Experimental: Cohort HR-/HER2-
Hormone receptor negative, HER2 negative participants will receive SHR1316 in combination with bevacizumab plus cisplatin or carboplatin until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Other Name: HTI-1088
Other Name: Avastin
Other Name: Bobei
- Overall Response Rate in the CNS [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 24 months ]CNS ORR will be assessed by the investigator according to RANO-BM criteria. According to these criteria Complete Response (CR) will be defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions, no corticosteroids; stable or improved clinically. Partial Response (PR) will be defined as a decrease of at least 30% in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD, sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically.
- Clinical Benefit Rate in the CNS [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 24 months ]CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.
- Progression-free survival [ Time Frame: Up to 2 years ]PFS will be defined as the time from the first dose of treatment to death or disease progression.
- Overall survival [ Time Frame: Up to 2 years ]OS will be defined as the time from the first dose of treatment to death for any cause.
- First progression site [ Time Frame: Up to 2 years ]The first lesion to progress.
- Safety as assessed by percentage of patients with any Adverse Event [ Time Frame: Up to 2 years ]Adverse event according to NCI-CTC AE 5.0
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): NCT04303988
|Contact: Zhang Jianfirstname.lastname@example.org|
|Contact: Li Ting||13917792964|
|Study Director:||Jian Zhang,MD||Fudan University|