Breast CancerPhase 2PALPETBIONCT03560856
A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer
A Phase 2 study testing Fulvestrant + palbociclib in people with Breast Cancer and HR+/HER2-negative Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported. In the PALOMA 3 study, the combination of Fulvestrant+ Palbociclib seems to be active in patients whose tumour harbours ESR1 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, HR+/HER2-negative Breast Cancer, Metastasis
- What is being tested?
- Fulvestrant + palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2018to 1 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older, who are either:
- Postmenopausal, as defined by at least one of the following criteria:
- 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 Follicle-Stimulating Hormone (FSH) level within the laboratory's reference range for postmenopausal females;
- Documented bilateral oophorectomy;
- Medically confirmed ovarian failure.
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- Histologically or cytologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- Documentation of ER-positive and/or PR-positive tumor (>10% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.
- Documented HER2-negative tumor based on local testing on most recent tumor biopsy:
- HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio <2 or for single probe assessment a HER2 copy number <4.
- Patients must satisfy the following criteria for prior therapy:
- Progressed while on or within 1 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal.
- One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy as a maintenance therapy.
- Endocrine therapy required being the most recent treatment.
- Patients could have been treated by EVEROLIMUS
- Except where prohibited by local regulations, all patients must agree to provide and have available a formalin-fixed paraffin embedded (FFPE) tissue biopsy taken at the time of presentation with recurrent or metastatic disease. A frozen de novo tissue biopsy is required at inclusion and at progression in a visceral, skin or lymph node lesion
- Patient must have measurable lesions (according to RECIST 1.1)
- Patients with only osteoblastic bone lesions are not eligible
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients must be treated by palbociclib+fulvestrant according to their Summary of Product Characteristics (SmPC) described bellow as a reminder :
- Adequate organ and marrow function defined as follows:
- ANC >1,500/mm3 (1.5 x 109/L);
- Platelets >100,000/mm3 (100 x 109/L);
- Hemoglobin > 9 g/dL (90 g/L);
- Serum creatinine <1.5 x Upper Limit of Normal (ULN) or estimated creatinine clearance >60 ml/min as calculated using the method standard for the institution;
- Total serum bilirubin <1.5 x ULN (<3 ULN if Gilbert's disease);
- AST and/or ALT <3 x ULN (<5.0 x ULN if liver metastases present);
- Alkaline phosphatase <2.5 x ULN (<5 x ULN if bone or liver metastases present).
- Resolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE Grade <1 (except alopecia).
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Patients covered by health insurance
Who cannot join
- Prior treatment with any Cyclin-Dependent Kinase (CDK) inhibitor or fulvestrant will not be allowed. Previous treatment with Everolimus will be allowed.
- Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before inclusion.
- Diagnosis of any other malignancy within 3 years prior to inclusion, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Patient with at least one criteria for not receiving palbociclib and/or fulvestrant described bellow as a reminder :
- current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers, and drugs that are known to prolong the QT interval.
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- major surgery, chemotherapy, radiotherapy, any investigational agents, or other anti-cancer therapy within 2 weeks before inclusion. Patients who received prior radiotherapy to >25% of bone marrow are not eligible independent of when it was received.
- QTc interval >480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
- any of the following within 6 months of inclusion: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE Grade <2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
- impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of palbociclib, such as history of GI surgery with may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE Grade >1.
- prior hematopoietic stem cell or bone marrow transplantation.
- known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant.
- known or possible hypersensitivity to fulvestrant or to any palbociclib excipients.
- known human immunodeficiency virus infection.
- Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or palbociclib+fulvestrant administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
- Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before inclusion in the current study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer (PALPETBIO)
The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported. In the PALOMA 3 study, the combination of Fulvestrant+ Palbociclib seems to be active in patients whose tumour harbours ESR1 mutations. This study will confirm these data on this population and will allow us to identify if other gene alterations or a genomic signature can correlate with fulvestrant +palbociclib resistance.
- Conditions
- Breast Cancer, HR+/HER2-negative Breast Cancer, Metastasis
- Being tested
- Fulvestrant + palbociclib
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulvestrant + palbociclibDrug
Patients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule).
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant 500mg + palbociclib 125 mg | Other | Patients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule). Receives: Drug: Fulvestrant + palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Progression-Free Survival is defined as the time from the date of inclusion to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD
Measured: 2 years
Secondary outcomes (4)
Overall survival
Overall Survival is defined as the time from the date of inclusion to the date of the death due to any cause
Measured: 2 years
Response
Objective Response (OR) defined by Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at 2 years.
Measured: 2 years
Clinical Benefit Response
Clinical Benefit Response (CBR): Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at week 24.
Measured: 24 weeks
Duration of Response (DoR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start27 Jun 2018 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560856
- Sponsor's protocol ID
- P170104J
- Acronym
- PALPETBIO
- Status last verified
- May 2018
- First submitted
- 1 Jun 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer (PALPETBIO)
- ClinicalTrials.gov ID
- NCT03560856
- Acronym / sponsor ID
- PALPETBIO / P170104J
- Conditions
- Breast Cancer, HR+/HER2-negative Breast Cancer, Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported. In the PALOMA 3 study, the combination of Fulvestrant+ Palbociclib seems to be active in patients whose tumour harbours ESR1 mutations. This study will confirm these data on this population and will allow us to identify if other gene alterations or a genomic signature can correlate with fulvestrant +palbociclib resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant 500mg + palbociclib 125 mg | Other | Drug: Fulvestrant + palbociclibPatients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Women 18 years of age or older, who are either:
- Histologically or cytologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- Documentation of ER-positive and/or PR-positive tumor (>10% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.
- Documented HER2-negative tumor based on local testing on most recent tumor biopsy:
- HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio <2 or for single probe assessment a HER2 copy number <4.
Key exclusion criteria (17 listed)
- Prior treatment with any Cyclin-Dependent Kinase (CDK) inhibitor or fulvestrant will not be allowed. Previous treatment with Everolimus will be allowed.
- Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before inclusion.
- Diagnosis of any other malignancy within 3 years prior to inclusion, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Patient with at least one criteria for not receiving palbociclib and/or fulvestrant described bellow as a reminder :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fulvestrant + palbociclibPatients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule). | Drug | Fulvestrant 500mg + palbociclib 125 mg |
Primary outcome
Progression Free survival
Time frame: 2 years
Progression-Free Survival is defined as the time from the date of inclusion to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD
4 secondary outcomes
Overall survival
Time frame: 2 years
Response
Time frame: 2 years
Clinical Benefit Response
Time frame: 24 weeks
Duration of Response (DoR).
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant + palbociclib in people with Breast Cancer and HR+/HER2-negative Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TEIXEIRA LUIS, MD PhD (142499613 ext. +33, luis.teixeira@aphp.frluis.teixeira@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.