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

Sponsor
Asociatia Oncohelp - Centrul de Oncologie Oncohelp (Other)
Overall Status
Recruiting
CT.gov ID
NCT05135104
Collaborator
MDX Research (Other)
150
1
11
13.6

Study Details

Study Description

Brief Summary

PALBO is a Non-Interventional, Single-Institution 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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Metastatic breast cancer (MBC) is the most advanced stage of breast cancer, where the disease has spread to distant sites beyond the axillary lymph nodes. At European level, MBC occurs in up to 20-30 percent of women diagnosed with early-stage breast cancer. At regional level, there are variations in newly diagnosed patients who present with metastatic disease. In high income countries fewer than 8% of patients are initially diagnosed with MBC, while the highest burden of MBC is carried by low and middle-income countries where up to 60% are initially diagnosed with MBC. Currently, the median overall survival for patients with MBC is approximately 2 to 3 years in developed countries, but lower in developing countries. In Romania, 8900 new cases of BC are diagnosed every year, with 80% being diagnosed in an advance stage of the disease (II, III, IV). Furthermore, after initial BC treatment, approximately 50% will develop MBC.

Cyclin-dependent kinase (CDK) 4/6 inhibitors (Palbociclib, ribociclib and abemaciclib) are now standard of care for the treatment of advanced hormone receptor positive (HR+) and HER2 negative (HER2-) breast cancer.

On 09 November 2016, the EC has approved IBRANCE® (Palbociclib) as the first CDK 4/6 inhibitor, to be used in combination with letrozol as first-line or in combination with fulvestrant in women who have received prior endocrine therapy, based on the results of PALOMA-1, PALOMA-2 and PALOMA-3 study results. Other phase III randomized trials have been reported and confirmed the efficacy of CDK4/6 inhibition in both first-line and endocrine resistant settings.

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.

An approximate number of 150 patients will be included in the present study which will take place in a research centre in Romania.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Non-Interventional, Single-Institution 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
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Outcome Measures

Primary Outcome Measures

  1. Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years] [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. Overall Survival (OS) investigation [ Time Frame: 2.5 years] [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.

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

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

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

Secondary Outcome Measures

  1. 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 first secondary objective of our study is to identify the medium duration of the treatment with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line.

  2. 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]

    The second secondary objective of our study is to identify the Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.

  3. PFS in a selected subgroup with KI67 mutation [2.5 years]

    Exploratory variable

  4. 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]

    Exploratory variable

  5. PFS in lobular/ductal/other histological subtypes [2.5 years]

    Exploratory variable

  6. PFS in a selected subgroup with Luminal B subtype [2.5 years]

    Exploratory variable

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adult women (≥ 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.

  2. 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.

  3. 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.

  4. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.

  5. Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries).

  6. Premenopausal or postmenopausal status.

6.1 Patients who are not postmenopausal must have undergone a treatment with LHRH agonist.

6.2 Postmenopausal status is defined as:

  1. prior bilateral surgical oophorectomy, or

  2. spontaneous cessation of regular menses for at least 12 consecutive months

  3. in case of doubt serum estradiol <20 umol/l and follicle stimulating hormone (FSH) levels >15 IU/L.

Exclusion Criteria:
  1. Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).

  2. Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asociatia Oncohelp - Centrul de Oncologie Oncohelp Timisoara Timiș Romania 300239

Sponsors and Collaborators

  • Asociatia Oncohelp - Centrul de Oncologie Oncohelp
  • MDX Research

Investigators

  • Principal Investigator: Cristina Marinela Oprean, MD, ASOCIATIA ONCOHELP - CENTRUL DE ONCOLOGIE ONCOHELP, DEPARTMENT OF MEDICAL ONCOLOGY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asociatia Oncohelp - Centrul de Oncologie Oncohelp
ClinicalTrials.gov Identifier:
NCT05135104
Other Study ID Numbers:
  • PALBO01/2021
First Posted:
Nov 26, 2021
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Asociatia Oncohelp - Centrul de Oncologie Oncohelp
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022