A phase III clinical trial, which tests the safety and efficacy of the combination of palbociclib and endocrine therapy to learn whether the combination of these drugs works for a specific form of breast cancer (hormone receptor positive / HER2-negative isolated locoregional recurrent breast cancer).
- Conditions
- patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancerMedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003553-19-FR
- Lead Sponsor
- International Breat Cancer Study Group (IBCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence in at least one of the sites below:
– Breast
– Chest wall including mastectomy scar and/or skin
– Axillary or internal mammary lymph nodes
? Completion of locoregional therapy:
– Completion of gross excision of recurrence within 6 months prior to randomization
– Completion of radiotherapy (if given) more than 2 weeks prior to randomization
? Negative or microscopically involved margins
? Female or male aged 18 years or older
? ECOG performance status 0 or 1
? Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ =1% by IHC
? Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified)
Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH/FISH
? Normal hematological, renal, and liver function
? The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review
? Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence
Patients must be affiliated to a Social Security System (or equivalent)
Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
? Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable
? Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy or FDG-PET-CT).
? Bilateral invasive breast cancer (in situ carcinoma of the contralateral breast is allowed)
? Inflammatory breast cancer
? Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions:
– Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible
– Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers
? Previous treatment with palbociclib or any other CDK 4/6 inhibitors
? Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization)
? Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety
? Contraindications or known hypersensitivity to the palbociclib or excipients
? Pregnant or lactating women; lactation has to stop before randomization
Participation in another therapeutic trial within the 30 days prior to randomization
Persons deprived of their liberty or under protective custody or guardianship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs iDFS compared to treatment with standard endocrine therapy alone for at least 3 years in patients with HR-positive / HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.;Secondary Objective: To assess the tolerability of 3 years of palbociclib in combination with standard endocrine therapy compared to standard endocrine therapy alone, as measured by adverse events.<br>To assess whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs other measures of efficacy as compared to treatment with standard endocrine therapy alone for at least 3 years in this patient population.;Primary end point(s): Invasive disease-free survival (iDFS);Timepoint(s) of evaluation of this end point: from randomization until first appearance of invasive local, regional, or distant recurrence
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Tolerability: Adverse events<br>- Breast cancer-free interval (BCFI)<br>- Distant recurrence-free interval (DRFI)<br>- Overall survival (OS);Timepoint(s) of evaluation of this end point: -Adverse events: at occurance , from randomization until end of treatment visit<br>- BCFI: time from randomization until first appearance of invasive local, regional, or distant recurrence<br>- DRFI: time from randomization until first appearance of distant recurrence of breast cancer<br>- OS: time from randomization until death from any cause