Palbociclib for HR positive Isolated Local or Regional Recurrence of Breast Cancer

Phase 3

Active, not recruiting

• Conditions: Female or male patients with histologically confirmed HR-positive, HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.

• Registration Number: 2024-510776-20-00
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-04
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 381

Inclusion Criteria

• Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence of a primary invasive breast cancer 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 - Written Informed Consent (IC) prior to randomization

Exclusion Criteria

• 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 synchronous or metachronous 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 - History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. History of prior radiation pneumonitis is not an exclusion criterion. - Pregnant or lactating women; lactation has to stop before randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause.		The primary endpoint iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are: - Adverse events, according to CTCAE version 5 - Breast cancer-free interval (BCFI) - Distant recurrence-free interval (DRFI) - Overall survival (OS)		The secondary endpoints are: - Adverse events, according to CTCAE version 5 - Breast cancer-free interval (BCFI) - Distant recurrence-free interval (DRFI) - Overall survival (OS)

Trial Locations

Locations (37)

National Institute of Oncology; 🇭🇺 Budapest, Hungary

Medical University Of Graz; 🇦🇹 Graz, Austria

Medizinische Universitaet Innsbruck; 🇦🇹 Innsbruck, Austria

SCRI CCCIT Ges.m.b.H.; 🇦🇹 Salzburg, Austria

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen De La Macarena; 🇪🇸 Sevilla, Spain

Institut Catala D'oncologia; 🇪🇸 Girona, Spain

Hospital Universitario Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

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National Institute of Oncology

🇭🇺Budapest, Hungary

Gabor Rubovszky

Site contact

0036206154455

garub@oncol.hu