Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China

NCT04526028 | Unknown FDA Drug

• 1 other identifier: CIH-TZS-20190912
• Study Type: observational
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficacy and safety of CDK4/6 inhibitor Palbociclib in combination with Fulvestrant versus Fulvestrant in female patients with HR+/HER2- advanced breast cancer in a real world setting in China. Primary study endpoint: progression-free survival (PFS). Secondary study endpoints: overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), objective response duration (DOR) and safety.

Conditions

Breast Cancer; Fulvestrant; Palbociclib

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  To compare the progression-free survival for patients receiving CDK4/6 Inhibitor Palbociclib in Combination with Fulvestrant Versus Fulvestrant

  41 months

Study Arms (2)

Palbociclib combined with Fulvestrant

Drug: Fulvestrant Injectable Product; Drug: Palbociclib

Fulvestrant

Drug: Fulvestrant Injectable Product

Interventions

Fulvestrant Injectable Product DRUG

Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.

Fulvestrant; Palbociclib combined with Fulvestrant

Palbociclib DRUG

Palbociclib is in the form of oral capsules, which are divided into three specifications: 75 mg, 100 mg and 125 mg. The recommended dose is 125 mg once daily for 21 days, followed by 7 days (3/1 dosage regimen), 28 Day is a treatment cycle.

Palbociclib combined with Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Female patients with advanced breast cancer aged 18 years or older. 2. Postmenopausal or premenopausal/perimmenopausal women can be enrolled. 3. HR-positive, HER2-negative breast cancer patients. 4. Patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteogenic) bone lesions in the absence of measurable lesions.

You may qualify if:

• (2a) Meet any of the following criteria: a) recurrence and metastasis of evidence of imaging progression for more than 1 year after completion of endocrine neoadjuvant or adjuvant therapy and no endocrine therapy for recurrent metastatic disease; b) A primary metastatic disease has occurred and no previous endocrine therapy has been received.
• (2b) Meet any of the following criteria: a) previous endocrine-assisted treatment completed 2 years and above, and recurrence and metastasis of evidence of imaging progression during treatment, and no subsequent endocrine therapy after progression; b) completion of adjuvant endocrine After treatment, recurrence and metastasis of evidence of imaging progression occurred within 1 year, and no subsequent endocrine therapy was received after progression; c) recurrence and metastasis occurred after more than 1 year after completion of adjuvant endocrine therapy, and then received anti-estrogen drugs or aromatase inhibitors as evidence of disease progression after first-line endocrine therapy and evidence of imaging progression, patients may not have more than 1 line of endocrine therapy for recurrent metastatic disease; d) primary metastatic disease, and subsequent anti-acceptance Estrogen drugs or aromatase inhibitors as a first-line metastatic disease after endocrine therapy disease progression and evidence of imaging progression, patients can not receive more than 1 line of endocrine therapy for metastatic disease.
• \) Postmenopausal or premenopausal/perimmenopausal women can be enrolled. In postmenopausal state, defined as meeting at least one of the following criteria: previous bilateral ovarian surgery; age≥60 years; age \<60 years, menopause for at least 12 months (not because of chemotherapy, tamoxifen, toremifene or ovarian suppression) and follicle stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.
• Premenopausal or perimenopausal women can also be enrolled, but must be willing to receive LHRHa treatment during the study.
• \) Pathological examination confirmed HR-positive, HER2-negative breast cancer patients with local recurrence or metastasis evidence.
• ER-positive and/or PR-positive is defined as: positively stained tumor cells account for ≥1% of all tumor cells (confirmed by the investigator at the test center);
• HER2-negative is defined as: standard immunohistochemistry (IHC) detection is 0/1+; ISH detection: the HER2/CEP17 ratio is less than 2.0 or the HER2 gene copy number is less than 4 (confirmed by the researcher at the test center).
• \) According to the RECIST1.1 standard, patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteogenic) bone lesions in the absence of measurable lesions.
• (6a) The following criteria are met: premenopausal patients are allowed to receive ≤1 line of chemotherapy for recurrent metastatic disease, and postmenopausal patients are not allowed to receive any chemotherapy for recurrent metastatic disease.
• (6b) The following criteria are met: ≤1 line of chemotherapy for recurrent metastatic disease is allowed.
• \) The patient is receiving any of the following treatment regimens, the first dose is administered within 2 months prior to enrollment, and the first efficacy assessment has not been performed: a) Palbociclib in combination with Fulvestrant; b) Fulvestrant.

You may not qualify if:

• HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or fluorescent in situ hybridization.
• Female patients during pregnancy or lactation.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300061, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhongsheng Tong, Master

CONTACT

+86 18622221181; 18622221181@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: September 13, 2019
• Primary Completion: February 28, 2023
• Study Completion: May 31, 2023
• Last Updated: August 25, 2020

Record last verified: 2019-11

Locations

CN (1)