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Compares treatment options for ER+ Breast Cancer
Official title A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT04985266
What this study is testing
What is Palbociclib 125Mg Tab?
Palbociclib 125Mg Tab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for er+ breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for ctDNA Surveillance:
- Written informed consent to participate in the trial and to donation of tissue and blood samples
- Male or female patients aged 18 years or older
- ECOG performance status 0, 1 or 2 (see https://ecog-acrin.org/resources/ecog-performance-status)
- Histologically proven primary ER+ (Allred score 6/8 or greater, or stain in ≥10% of cancer cells) and HER2- (immunohistochemistry 0/1+ and/or...
You likely can't join if
- for ctDNA Surveillance:
- Any concurrent or planned treatment for the current diagnosis of breast cancer other than adjuvant endocrine therapy or a bisphosphonate.
- Patients with prior exposure to a CDK 4/6 inhibitor as part of standard of care may enrol only after at least 12 months from completing CDK4/6...
- Prior exposure to therapeutic dose of fulvestrant is not permitted. One subtherapeutic dose of fulvestrant is permitted.
- Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for non-melanoma carcinoma of the skin or...
- Patients previously entered into a therapeutic trial where experimental therapy is continued post-surgery. Patients who have entered a clinical trial...
See the full eligibility criteria
Who can join
- for ctDNA Surveillance:
- Written informed consent to participate in the trial and to donation of tissue and blood samples
- Male or female patients aged 18 years or older
- ECOG performance status 0, 1 or 2 (see https://ecog-acrin.org/resources/ecog-performance-status)
- Histologically proven primary ER+ (Allred score 6/8 or greater, or stain in ≥10% of cancer cells) and HER2- (immunohistochemistry 0/1+ and/or negative by in situ hybridization) breast cancer as determined by local...
- Patients with high risk early stage breast cancer according to at least one of the following criteria: Primary surgery (no other treatment prior to surgery) A. Four or more involved axillary lymph nodes or positive...
- Available tissue from one archival tumour tissue sample (either from diagnostic biopsy, primary surgery or where available residual disease post-neoadjuvant chemotherapy)
- No evidence of macroscopic distant metastatic disease or incurable locally advanced disease on staging scans conducted at any time since initial diagnosis.
- Patients receiving standard endocrine therapy with aromatase inhibitors (letrozole, anastrazole, exemestane), tamoxifen, or combination of such for a minimum of 6 months\ and maximum of 7 years duration with an...
- Patients must have had surgery achieving clear margins (as per local guidelines)
- Female and male patients of reproductive potential must be willing to use an adequate method of contraception for the first three years of the trial, if assigned by chance to standard endocrine therapy for the duration...
- Patients willing to have frequent blood tests. for treatment phase:
- Signed informed consent for treatment
- ECOG performance status 0, 1 or 2
- Women of childbearing potential should have a negative serum pregnancy test prior to randomisation. If randomisation occurs more than 72 hours prior to receiving the first dose of treatment the test must be repeated...
- Female and male patients of childbearing potential must be willing to use an adequate method of contraception (section 4.6), starting with the first dose of treatment through 4 weeks after the last dose of treatment if...
- Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Haemoglobin ≥ 100 g/L
- INR ≤1.5
- Creatinine \<1.5 x ULN and creatinine clearance ≥30ml/min
- Total bilirubin \< ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.
- Alanine aminotransferase (ALT) \< 2.5 x ULN
- Aspartate aminotransferase (AST) \< 2.5 × ULN
- Patients must be post-menopausal OR Pre- or peri-menopausal patients or men may be enrolled if they have ovarian/gonadal suppression with licensed GnRH analogues. Patients must have commenced licensed GnRH analogues at...
- Age ≥60 years;
- Age \<60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH levels within the institutional laboratory's...
- Documented bilateral oophorectomy;
What rules you out
- for ctDNA Surveillance:
- Any concurrent or planned treatment for the current diagnosis of breast cancer other than adjuvant endocrine therapy or a bisphosphonate.
- Patients with prior exposure to a CDK 4/6 inhibitor as part of standard of care may enrol only after at least 12 months from completing CDK4/6 therapy.
- Prior exposure to therapeutic dose of fulvestrant is not permitted. One subtherapeutic dose of fulvestrant is permitted.
- Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ
- Patients previously entered into a therapeutic trial where experimental therapy is continued post-surgery. Patients who have entered a clinical trial of a CDK4/6 inhibitor in the adjuvant setting are not eligible...
- Treatment with an unlicensed or investigational product within 4 weeks prior registration to trial
- Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic...
- Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting...
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or...
- Clinically significant uncontrolled heart disease including any of the following:
- History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry
- Symptomatic congestive heart failure
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
- Cardiac arrhythmia.
- History of pneumonitis, interstitial lung disease or pulmonary fibrosis
- Known history of Human Immunodeficiency Virus (HIV) (testing not required as part of study screening)
- Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)
- Females who are known to be pregnant or breastfeeding
- History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH)...
- Child-Pugh class C hepatic impairment or creatinine clearance \< 30ml/min.
- Patient with bilateral tumours, or unilateral multifocal cancers with multiple separate primary cancers.(Multifocal cancer that reflects a single primary cancer, in the opinion of the investigator, are eligible)...
- Evidence of recurrent disease (metastatic or local, see section 6.6 for management of patients with potentially curable local recurrences) on staging scans conducted since positive ctDNA result
- Known hypersensitivity to the excipients of palbociclib plus fulvestrant
- Any anti-cancer treatment since enrolling in the TRAK-ER study other than hormonal therapy or a bisphosphonate. Prior exposure to fulvestrant is not permitted.
- Diagnosis of an alternative cancer since enrolment in the trial other than non-melanoma cancer of the skin or cervical carcinoma in situ
- Patient has had major surgery within 4 weeks prior to starting trial treatment or has not recovered from major side effects of such procedure
- Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with unfractionated heparin, low molecular weight heparin (LMWH), or a direct-acting...
- Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic...
- Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting...
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or...
- Clinically significant uncontrolled heart disease including any of the following:
- History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry
- Symptomatic congestive heart failure
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
- Cardiac arrhythmia.
- Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:
- Medications that are strong inducers or inhibitors of CYP3A4 (section 8.5.2)
- Herbal preparations/medications, dietary supplements, fruits (e.g grapefruit, pomelos, starfruit, Seville oranges) and their juice
- History of pneumonitis, interstitial lung disease or pulmonary fibrosis
- Known history of HIV (testing not required as part of study screening)
- Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)
- Patient has a history of non-compliance to medical regimen
- History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH)...
- Females who are known to be pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Annecy, France
- Avignon, France
- Blois, France
- Bordeaux, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nantes, France
- Nice, France
- Paris, France
- Reims, France
- Rennes, France
- Rouen, France
- Saint-Priest-en-Jarez, France
- Toulouse, France
- London, Barnet, United Kingdom
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Annecy, France; Avignon, France; Blois, France; Bordeaux, France; Clermont-Ferrand, France and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.