Status:
UNKNOWN
Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The international treatment guidelines now include recommendations for the use of CDK 4/6 inhibitors in combination with hormone agents for the treatment of postmenopausal women with hormone-receptor-...
Detailed Description
According to the early assessment(4 weeks) , this prospective study comprehensively investigate TTR of Palbociclib+ET in the first line treatment for HR+/HER2- MBC patients in China real-world study. ...
Eligibility Criteria
Inclusion
- Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
- Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor positive (ER+, \> 10%) breast cancer based on local laboratory results.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- Postmenopausal women.
- At least one measurable lesion as defined per RECIST v.1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Adequate organ and marrow function.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications including any of the following:
- massive uncontrolled effusions \[pleural, pericardial, peritoneal\]
- pulmonary lymphangitis,
- over 50% liver involvement
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis,or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.
- Prior treatment with any CDK4/6 inhibitor.
- QTc \>480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
- Female patients who are pregnant or nursing.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04858997
Start Date
April 22 2021
End Date
June 30 2023
Last Update
July 15 2021
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022