Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients

July 13, 2021 updated by: Zhejiang Cancer Hospital

An Open-label, Prospective Study of Tumor Response Time of Palbociclib in Combination With AI in Real-world First-line Treatment of Postmenopausal Chinese Patients With ER (+) HER2 (-) Metastatic Breast Cancer

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-positive/HER2-negative ABC as the first-line standard therapy in endocrine sensitive patients.

Nevertheless, it is generally thought that chemotherapy is associated with greater and earlier tumor response, especially in case of high burden of disease. In a retrospective analysis of real-world clinical practice (2002-2012) from US, only 60% of patients initiated ET as the first treatment following metastatic diagnosis . In the real-life world of China, a large number of HR+/HER2- ABC patients with non-visceral crisis also received chemotherapy in first-line treatment, even though the ORR is similar compared with CDK4/6 inhibitors with endocrine therapy. Zhejiang Cancer Hospital retrospective analysis of 5 cases of advanced breast cancer first-line use of Ibance + ET, they were evaluated within 50 days (from 27days to 50days).

Based on the early response time observed in real-world data mentioned above, it is proposed a prospective study to further observe the tumor reduction rate in real-world, including to identify the time of patient symptom improvement according to the quality of life scale.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Furthermore, evaluate the Early Tumor Shrinkage(ETS) of Palbociclib + ET, and assess Treatment Free Interval (TFI) with TTR and ETS；TFI was analyzed at the following time points: ≤24, >24, ≤36, > 36, ≤48, >48 months.

Accroding to the follow-up of QoL questionnaire, understand the clinical symptoms improvements time.

Meanwhile, cooperation with radiology department, establish a model for predicting early response by observing the imaging and clinical pathological characteristics of patients with ETS.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen-Ming Cao, Ph.D., M.D.
  • Phone Number: 8613858064001
  • Email: caowm@zjcc.org.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Wen-Ming Cao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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.
  2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor positive (ER+, > 10%) breast cancer based on local laboratory results.
  3. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
  4. Postmenopausal women.
  5. At least one measurable lesion as defined per RECIST v.1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  7. Adequate organ and marrow function.
  8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. 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
  2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis,or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
  3. 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.
  4. Prior treatment with any CDK4/6 inhibitor.
  5. 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).
  6. Female patients who are pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Palbociclib-AI
ER(+)/HER2(-) patients with histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease receive palbociclib PO daily on days 1-21, combined with AI as first-line treatment Disease assessments measured by CT imaging will be performed at first 4 weeks, 8weeks, then every 8weeks (± 7 days) from the date of randomization until radiographic/clinical documentation of progressive disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Drug: Palbociclib
Palbociclib,125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Other Names:
  • Ibrabce
Drug: AI
AI, orally once daily (continuously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Tumor Shrinkage (ETS)
Time Frame: 4 weeks, 8weeks
10% change in the sum of the longest diameters (SLD) of target lesions at the first scan after 4weeks and 8weeks of treatment.
4 weeks, 8weeks
Time To Response (TTR)
Time Frame: Up to approximately 24 months
Time to first documented complete of partial response.
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
ORR is defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Up to approximately 24 months
Number of participants with Adverse Events per CTCAE version 4.03 and type
Time Frame: Up to approximately 24 months
Safety will be determined by type, severity of adverse events per CTCAE version 4.03 and type
Up to approximately 24 months
Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Time Frame: Up to approximately 24 months
At least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.
Up to approximately 24 months
Overall Survival (OS)
Time Frame: Randomization to death from any cause, through the end of study (approximately 60months)]
time to death due to any cause
Randomization to death from any cause, through the end of study (approximately 60months)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Wen-Ming Cao, Ph.D., M.D., Department of Breast Medical Oncology, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAL-ZJCC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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