PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (NCT03079011) | Clinical Trial Compass
CompletedPhase 3
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
France1,017 participantsStarted 2017-03-22
Plain-language summary
This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Women with proven loco-regionally recurrent or metastatic adenocarcinoma of the breast not amenable to curative therapy with disease considered potentially sensitive to aromatase inhibitors Note: patients relapsing while on adjuvant tamoxifen or other non-aromatase inhibitor adjuvant endocrine therapy and patients relapsing more than one year after the end of aromatase inhibitor adjuvant therapy are eligible for the present study;
✓. Age ≥18 years;
✓. Life expectancy \>3 months;
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
✓. Estrogen Receptor (ER)-positive and HER2-negative breast cancer. Where available, assessment of Estrogen Receptor status should be based on the most recent tumor sample; to be considered as ER-positive, the most recent breast cancer tissue examined must display at least 10% of cancer cells with positive ER staining;
✓. Tumor block (primary tumor or metastasis) available;
✓. No prior systemic anti-cancer therapy for metastatic or advanced disease (chemotherapy, targeted therapy or hormone therapy); prior initiation of LHRH agonist or bone-directed agents is however allowed);
✓. Menopausal patients or patients with suppressed ovarian function
Exclusion criteria
✕. Locally advanced breast cancer or loco-regional relapse amenable for any treatment with curative intent;
✕. Her2-positive or equivocal tumor status either on the primary or on the recurrent tumor, defined as IHC3+, Fish/Cish amplified or Fish/Cish equivocal according to the ASCO2015 criteria;
What they're measuring
1
Incidence of treatment-emergent Adverse Events
Timeframe: Throughout study completion, up to 4 years
2
Progression-free survival (Step 2)
Timeframe: From randomization to disease progression or death, up to 4 years
✕. Prior endocrine therapy in the metastatic setting is not allowed;
✕. Prior treatment with any CDK 4/6 inhibitor in the adjuvant or metastatic setting (neoadjuvant/preoperative treatment is allowed); however, prior therapy with another targeted treatment in the adjuvant setting is allowed;
✕. Visceral crisis: Advanced, symptomatic, visceral spread that is at risk of life-threatening complication in the short term and that requires chemotherapy;
✕. Any major surgery (defined as requiring general anaesthesia) or significant traumatic injury within 4 weeks of treatment initiation or patients that may require major surgery during the course of the study; however, surgical diagnostic procedure is allowed (even if performed under general anaesthesia);
✕. Known, active bleeding diathesis;
✕. Any serious known concomitant systemic disorder (e.g. known active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti-coagulation treatment (the use of low molecular weight heparin is allowed);