Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period

NCT05135104 | Unknown FDA Drug

• 1 other identifier: PALBO01/2021
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 7

Brief Summary

PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer; Metastatic Breast Cancer; Her2 Negative Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years]

  DCR will be calculated per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.

  2.5 years

• Overall Survival (OS) investigation [ Time Frame: 2.5 years]

  OS will be defined as the elapsed time from the enrolment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will at 1, 2 and 3 months until death or withdrawal of consent from the study.

  2.5 years

• Objective Response Rate (ORR) investigation [ Time Frame: 2.5 years]

  ORR will be defined as the proportion of the patients with a confirmed CR or PR, as per mRECIST V1.1 criterion.

  2.5 years

• Duration of Response (DOR) investigation [ Time Frame: 2.5 years]

  DOR will be defined as the elapsed time from documented tumour response to documented disease progression.

  2.5 years

Secondary Outcomes (6)

• The medium duration of the treatment with Palbociclib in combination with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line

  2.5 years

• The Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.

  6 months after therapy start

• PFS in a selected subgroup with KI67 mutation

  2.5 years

• PFS in a selected subgroup of subjects with lower levels of HER2 expression (HER2-low) defined as HER2 immunohistochemistry 1+ or 2+, but FISH negative

  2.5 years

• PFS in lobular/ductal/other histological subtypes

  2.5 years

Interventions

Palbociclib DRUG

Palbociclib, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division. Palbociclib has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases. Therapeutic indications: Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or MBC: * in combination with an aromatase inhibitor; * in combination with fulvestrant in women who have received prior endocrine therapy.

Also known as: Ibrance

Eligibility Criteria

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

Study Population

The study population will consist of subjects aged 18 years and older with a confirmed diagnosis of Estrogen Receptor Positive, HER2 Negative MBC. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.

You may qualify if:

• Adult women and men (≥ 18 years of age) with proven initial diagnosis of breast cancer with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy.
• Documentation of histologically or cytologically confirmed diagnosis of breast cancer with IHC of estrogen receptor (ER) expression \> 1% and/or progesterone receptor (PR) expression \>1 % breast cancer based on local laboratory results.
• Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0.
• Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
• Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries).
• Premenopausal or postmenopausal status.
• Patients who are not postmenopausal must have undergone a treatment with LHRH agonist.
• Postmenopausal status is defined as:
• prior bilateral surgical oophorectomy, or
• spontaneous cessation of regular menses for at least 12 consecutive months
• in case of doubt serum estradiol \<20 umol/l and follicle stimulating hormone (FSH) levels \>15 IU/L.

You may not qualify if:

• Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
• Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).

Sponsors & Collaborators

• Asociatia Oncohelp - Centrul de Oncologie Oncohelp: lead
• MDX Research: collaborator

Study Sites (7)

Asociatia Oncohelp - Centrul de Oncologie Oncohelp

Timișoara, Timiș County, 300239, Romania

RECRUITING

Spitalul Clinic de Obstetrică Și Ginecologie Filantropia

Bucharest, 011171, Romania

RECRUITING

Institutul Oncologic "Prof. Dr I. Chiricuta"

Cluj-Napoca, 400015, Romania

RECRUITING

Spitalul Clinic Județean de Urgență Cluj-Napoca

Cluj-Napoca, 400349, Romania

RECRUITING

Centrul de Oncologie "Sf. Nectarie"

Craiova, 200746, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Spitalul Clinic Județean de Urgență Oradea

Oradea, 410469, Romania

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

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

Study Officials

• Cristina Marinela Oprean, MD

  ASOCIATIA ONCOHELP - CENTRUL DE ONCOLOGIE ONCOHELP, DEPARTMENT OF MEDICAL ONCOLOGY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Oprean, PI

CONTACT

+40 721 893 630; coprean@yahoo.com

Ramona Petrita, CSO

CONTACT

+40 721 893 630; ramona.petrita@mdxresearch.eu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 26, 2021
• Study Start: December 15, 2021
• Primary Completion: March 25, 2024
• Study Completion: May 25, 2024
• Last Updated: May 17, 2023

Record last verified: 2022-12

Locations

RO (7)