Clinical trial • Phase IV • Oncology

PALBOCICLIB for Early breast cancer

Phase IV trial of PALBOCICLIB for Early breast cancer.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Early breast cancer
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 15-10-2024
First CTIS Authorization Date: 28-10-2024

Trial design

Letrozole Sandoz 2.5 mg (oral, 2.5 mg); Paclitaxel Accord 6 mg/ml concentrate for infusion (intravenous, max 90 mg/m2 reported); TAMOXIFEN SANDOZ 20 mg (oral, 20 mg); Anastrozol Sandoz 1 mg (oral, 1 mg); Exemestan Sandoz 25 mg (oral, 25 mg). (Doses/schedules provided as in CTIS product entries; no detailed schedule/timing specified in record.)-controlled Phase IV trial across 3 sites in Sweden.

Comparator: Letrozole Sandoz 2.5 mg (oral, 2.5 mg); Paclitaxel Accord 6 mg/ml concentrate for infusion (intravenous, max 90 mg/m2 reported); TAMOXIFEN SANDOZ 20 mg (oral, 20 mg); Anastrozol Sandoz 1 mg (oral, 1 mg); Exemestan Sandoz 25 mg (oral, 25 mg). (Doses/schedules provided as in CTIS product entries; no detailed schedule/timing specified in record.)
Target Sample Size: 180

Eligibility

Recruits 180 Vulnerable population selected (isVulnerablePopulationSelected=true). Inclusion requires "Written informed consent". Subject information and informed consent form documents are listed (L1_SIS and ICF PREDIX-LumB). No further details on assent, proxy consent or age-specific consent documents are provided in the record..

Pregnancy Exclusion: Pregnancy or lactation
Vulnerable Population: Vulnerable population selected (isVulnerablePopulationSelected=true). Inclusion requires "Written informed consent". Subject information and informed consent form documents are listed (L1_SIS and ICF PREDIX-LumB). No further details on assent, proxy consent or age-specific consent documents are provided in the record.

Inclusion criteria

{"criterion_text":"- Written informed consent\n- Female or male patients with breast cancer confirmed by histology\n- Tumor and blood samples available. Luminal type confirmed by immunohistochemistry with ER≥10 %, not not HER2 3+/amplified\n- Age 35 years or older. Elderly patients in condition adequate for planned therapy.\n- Primary breast cancer >20 mm in diameter and/or verified regional lymph node metastases\n- Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders\n- ECOG performance status 0-1\n- Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well- defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available."}

Exclusion criteria

{"criterion_text":"- Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum\n- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix\n- Patients in child-bearing age without adequate contraception\n- Pregnancy or lactation\n- Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders."}

Endpoints

Primary endpoints

{"endpoint_text":"- Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment","definition_or_measurement_approach":"Assessment of clinical and radiological objective response after completion of the first 12-week period of primary medical treatment (timing specified as after the first 12-week period)."}

Secondary endpoints

{"endpoint_text":"- Pathological objective response to primary medical treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Sequencing of chemotherapy versus endocrine treatment plus palbociclib","definition_or_measurement_approach":""}
{"endpoint_text":"- Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer","definition_or_measurement_approach":""}
{"endpoint_text":"- Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Safety","definition_or_measurement_approach":""}
{"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
{"endpoint_text":"- Frequency of breast-conserving surgery","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 180
Recruitment Window Months: 189
Consent Approach: Participants must provide "Written informed consent" (principal inclusion criterion). Subject information and informed consent form documents are listed (L1_SIS and ICF PREDIX-LumB and recurrence version). No details in the record about assent, age-specific consent forms or languages provided.

Geography

Total Number Of Sites: 3
Total Number Of Participants: 180

Sweden

Earliest CTIS Part Ii Submission Date: 14-10-2024
Latest Decision Or Authorization Date: 03-09-2025
Processing Time Days: 324
Number Of Sites: 3
Number Of Participants: 180

Sites

Site Name: Capio S:t Goerans Sjukhus AB
Department Name: Bröstcentrum
Contact Person Name: Erika Isaksson Friman
Contact Person Email: Erika.Isaksson-Friman@capiostgoran.se

Site Name: Karolinska University Hospital
Department Name: Tema Cancer
Contact Person Name: Alexios Matikas
Contact Person Email: alexiosmatikas@ki.se

Site Name: Soedersjukhuset AB
Department Name: Onkologi
Contact Person Name: Elin Barnekow
Contact Person Email: elin.barnekow@regionstockholm.se

Sponsor

Primary sponsor

Full Name: Karolinska University Hospital
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Sweden

Investigational products

Investigational Product Name: IBRANCE 125 mg film-coated tablets
Active Substance: PALBOCICLIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Starting Dose: 125 mg
Maximum Dose: 125 mg

Investigational Product Name: Letrozole Sandoz 2,5 mg filmdragerade tabletter
Active Substance: LETROZOLE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Starting Dose: 2.5 mg
Maximum Dose: 2.5 mg

Investigational Product Name: Paclitaxel Accord 6 mg/ml koncentrat till infusionsvätska, lösning
Active Substance: PACLITAXEL
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Starting Dose: 90 mg/m2
Maximum Dose: 90 mg/m2

Investigational Product Name: TAMOXIFEN SANDOZ 20 mg
Active Substance: TAMOXIFEN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Starting Dose: 20 mg
Maximum Dose: 20 mg

Investigational Product Name: Anastrozol Sandoz 1 mg filmdragerade tabletter
Active Substance: ANASTROZOLE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Starting Dose: 1 mg
Maximum Dose: 1 mg

Investigational Product Name: Exemestan Sandoz 25 mg, filmdragerade tabletter
Active Substance: EXEMESTANE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Starting Dose: 25 mg
Maximum Dose: 25 mg

Combination Treatment: Yes

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