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

Primary Purpose

Breast Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Palbociclib

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palbociclib-AI

Arm Description

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.

Outcomes

Primary Outcome Measures

Early Tumor Shrinkage (ETS)

10% change in the sum of the longest diameters (SLD) of target lesions at the first scan after 4weeks and 8weeks of treatment.

Time To Response (TTR)

Time to first documented complete of partial response.

Secondary Outcome Measures

Objective Response Rate (ORR)

ORR is defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1)

Number of participants with Adverse Events per CTCAE version 4.03 and type

Safety will be determined by type, severity of adverse events per CTCAE version 4.03 and type

Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30

At least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.

Overall Survival (OS)

time to death due to any cause

Full Information

NCT ID

NCT04858997

First Posted

March 24, 2021

Last Updated

July 13, 2021

Sponsor

Zhejiang Cancer Hospital

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04858997

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 22, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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-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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Palbociclib-AI

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Palbociclib

Other Intervention Name(s)

Ibrabce

Intervention Description

Palbociclib,125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Intervention Type

Drug

Intervention Name(s)

Intervention Description

AI, orally once daily (continuously)

Primary Outcome Measure Information:

Title

Early Tumor Shrinkage (ETS)

Description

10% change in the sum of the longest diameters (SLD) of target lesions at the first scan after 4weeks and 8weeks of treatment.

Time Frame

4 weeks, 8weeks

Title

Time To Response (TTR)

Description

Time to first documented complete of partial response.

Time Frame

Up to approximately 24 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

ORR is defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1)

Time Frame

Up to approximately 24 months

Title

Number of participants with Adverse Events per CTCAE version 4.03 and type

Description

Safety will be determined by type, severity of adverse events per CTCAE version 4.03 and type

Time Frame

Up to approximately 24 months

Title

Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30

Description

At least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.

Time Frame

Up to approximately 24 months

Title

Overall Survival (OS)

Description

time to death due to any cause

Time Frame

Randomization to death from any cause, through the end of study (approximately 60months)]

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

postmenopausal

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen-Ming Cao, Ph.D., M.D.

Phone

8613858064001

caowm@zjcc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wen-Ming Cao, Ph.D., M.D.

Organizational Affiliation

Department of Breast Medical Oncology, Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen-Ming Cao, Ph.D., M.D.

Phone

8613858064001

caowm@zjcc.org.cn

First Name & Middle Initial & Last Name & Degree

Wen-Ming Cao

12. IPD Sharing Statement

Plan to Share IPD

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

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