EUCTR2018-003553-19-ESActive, not recruitingPhase 1
A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer - POLAR
International Breat Cancer Study Group (IBCSG)0 sites400 target enrollmentStarted: June 11, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •? Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence in at least one of the sites below:
- •– 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
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
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 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
Investigators
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