Breast Cancer MetastaticPhase 2PASIPHAENCT03322215
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
A Phase 2 study testing Palbociclib, Fulvestrant and Capecitabine in people with Breast Cancer Metastatic, run by Theodoros Foukakis at 9 sites in 2 countries.
Trial summary
This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Palbociclib, Fulvestrant and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 24 Oct 2017to 31 Oct 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or older.
- Postmenopausal, defined by at least one of the following criteria:
- Prior bilateral oophorectomy
- Age ≥60
- Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range according to the local laboratory reference. Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. OR Pre/perimenopausal if treated with goserelin that was initiated at least 4 weeks prior to randomization.
- Locally advanced or metastatic breast cancer deemed not amenable to curative surgery or curative radiation therapy.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Known estrogen-receptor positive and/or progesterone receptor positive breast cancer reported by local laboratory.
- Known HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
- Documented resistance to endocrine therapy (tamoxifen or aromatase inhibitors) defined as:
- Recurrence while on or within 12 months after the end of adjuvant endocrine treatment OR
- Progression while on or within 1 month after the end of endocrine treatment for advanced disease
- Previous chemotherapy for breast cancer including an anthracycline and a taxane (only one line for metastatic disease) is permitted.
- Radiological or other objective evidence (eg. new skin lesions or new lymph node lesions) of recurrence during or after the most recent systemic therapy for recurrent / metastatic disease prior to randomization.
- At least one tumor lesion accessible for biopsy that is a non-bone lesion or a predominantly lytic bone lesion, and that measures at least 10 mm in largest diameter. This lesion must not have been treated previously with irradiation (although the area may have been irradiated before the occurrence of the lesion).
- Patient is interested to participate in the trial, including the obligatory biopsies at a metastatic site/site before the start of study treatment.
- Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria or bone-only disease with at least one predominantly lytic or mixed bone lesion. For measurable disease, at least one site of disease must have largest tumor diameter of at least:
- 10 mm if measured by CT-scan, ultrasound, or physical exam
- 20 mm if measured by Chest X-ray
- 15 mm if suspiciously enlarged lymph node (short axis) see Eisenhauer et al. for more details All radiology studies must be performed within 28 days prior to registration (35 days if negative).
- Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
- Hematology: Absolute granulocytes > 1.5 x 109/L, Platelets > 100 x 109/L
- Biochemistry: Bilirubin ≤ 1.5 x upper limit of normal (ULN), Serum creatinine ≤ 1.5 x ULN.
- 14. APTT and INR ≤ 1.5 x ULN or institution accepted values for biopsy within 7 days prior to enrollment.
- Signed written informed consent provided by the patient.
Who cannot join
- Previous treatment with a CDK4/6 inhibitor, mTOR or PI3K inhibitor, fulvestrant or capecitabine. Short-term (<28 days) exposure to mTOR or PI3K inhibitor in the (neo)adjuvant setting is allowed.
- More than one prior chemotherapy lines for metastatic breast cancer. Previous (neo)adjuvant chemotherapy or for radically treated local or regional relapse is allowed in addition to one prior chemotherapy line for metastatic breast cancer Note: A chemotherapy line in advanced disease is an anticancer regimen that contains at least one chemotherapy agent and is given for 21 days or longer. If a cytotoxic chemotherapy regimen was discontinued for a reason other than disease progression and the decision for its discontinuation was taken within 21 days after starting it, then this regimen does not count as a "prior line of chemotherapy". Chemotherapy regimens composed of more than one drug are considered as one line of therapy.
- No measurable lesions amenable to biopsy (e.g. pleural effusion, ascites, skin rash, sclerotic bone etc).
- CNS metastases unless asymptomatic and adequately controlled with surgery or radiotherapy. Stable CNS disease is defined as CNS metastases or cord compression that have been definitively treated and the patient is clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Leptomeningeal carcinomatosis
- Advanced, symptomatic visceral spread (visceral crisis) with risk of life-threatening complications in the short term.
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- Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin, in situ melanoma or carcinoma in situ of the cervix.
- Active cardiac disease or a history of cardiac dysfunction including any of the following:
- History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- QTc > 480 msec as measured by Bazett's formula, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
- Uncontrolled hypertension.
- Patients being treated with drugs recognized as strong inhibitors or inducers of the isoenzyme CYP3A (including, but not limited, to - see table 6 - Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) continuously for at least 7 days during any time period in the last 2 weeks prior to randomization.
- Subjects with known dihydropyrimidine dehydrogenase (DHPD) deficiency or previous severe reactions to a fluoropyrimidine.
- Known abnormalities in coagulation such as bleeding diathesis or ongoing treatment with anticoagulants that preclude intramuscular administration of drugs.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- A previous metastatic tumor biopsy reported to be negative for both estrogen receptor and progesterone receptor (i.e. <1% for both), or positive for HER2 status (amplified ERBB2).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Skåne University Hospital
Malmö, 205 02
S:t Görans Hospital
Stockholm, 112 19
Karolinska University Hospital
Stockholm
Uppsala University Hospital
Uppsala, 751 85
United Kingdom4 sites
NHS Grampian
Aberdeen, AB15 6RE
Western General Hospital
Edinburgh, EH1 3EG
Beatson
Glasgow, G12 0XH
NHS Ayshire and Arran
Kilmarnock, KA2 OBE
About this study
Official title: A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance
This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included.
The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment.
Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Palbociclib, Fulvestrant, Capecitabine
- Keywords
- palbociclib, fulvestrant, capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
75-125 mg capsule orally once daily for 21 consecutive Days followed by 7 Days of treatment.
FulvestrantDrug
Also called Faslodex
500 mg intramuscularly Days 1 and 15 of cycle 1, and then on Day 1 of each subsequent 28-days cycle.
CapecitabineDrug
Also called Xeloda
Oral tablet 500 - 1,250 mg/m2 twice Daily, for 2 weeks followed by 1 week of rest.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib and fulvestrant | Experimental | Combination of palbociclib and fulvestrant
Palbociclib:
125 mg capsule administered orally once daily for 21 consecutive days followed by 7 days off treatment. Dose modification is recommended based on individual safety and tolerability.
Fulvestrant:
500 mg administered intramuscularly on days 1 and 15 of cycle 1, and then on day 1 of each subsequent 28-day cycle. Receives: Drug: Palbociclib; Drug: Fulvestrant |
| Capecitabine | Active comparator | 1,000 mg/m2 tablet administered orally twice daily for 2 weeks followed by one week of rest. Depending on adverse reactions, both dose escalation and dose reductions will be performed. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS), as assessed locally by the investigator.
Time to progression will be measured according to the RECIST criteria (version 1.1). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and - together with other lesions that are denoted as non-target lesions - followed until disease progression.
Measured: Time from the date of randomization to the date of progression, assessed up to 5 years.
Secondary outcomes (15)
Health related quality of life score EuroQol (EQ-5D)
Change from baseline to Health related quality of life score EuroQol (EQ-5D)
Measured: Baseline to progression up to 2 years
Health related quality of life score EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life Instrument (EORTC QLQ-C30).
Measured: Baseline to progression up to 2 years
Health related quality of life score EORTC QLQ-BR23
European Organisation for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ-BR23).
Measured: Baseline to progression up to 2 years
Correlation of efficacy measures with tumor Biomarkers
PgR IHC status (10% cut-off), will be correlated with PFS
Measured: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years..
Correlation of efficacy measures with tumor Biomarkers
Ki67 IHC status, will be correlated with PFS
Measured: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
ESR1 DNA somatic mutation status, will be correlated with PFS
Measured: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
Somatic mutations in cancer genes identified by sequencing, will be correlated with PFS
Measured: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
SET index, will be correlated with PFS
Measured: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Overall survival (OS)
Overall survival from time of randomization to death from any cause.
Measured: Time from randomization to death from any cause, assessed up to 5 years.
1-year survival
1-year survival rate from time of randomization to death from any cause.
Measured: Time from randomization to death from any cause, assessed up to 5 years.
2-year survival
2-year survival rate from time of randomization to death from any cause.
Measured: Time from randomization to death from any cause, assessed up to 5 years.
Objective response
Objective tumor response will be measured according to the RECIST criteria (version 1.1). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and - together with other lesions that are denoted as non-target lesions - followed until disease progression.
Measured: From randomization until end of treatment, assessed up to 5 years.
Duration of response
Response duration will be measured from the time measurement criteria for complete response (CR)/ partial response (PR) (whichever is first recorded) are first met until the first date that recurrent or progressive disease is objectively documented.
Measured: From randomization until end of treatment, up to 5 years.
Clinical Benefit Rate
Clinical Benefit Rate is defined as CR+PR+stable disease (SD) for > 24 weeks
Measured: From randomization until end of treatment, up to 5 years.
Frequency of adverse events (AE)
Adverse events will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Measured: From randomization until 28 days after the last dose of study medication, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start24 Oct 2017
- Primary completion30 Apr 2021
- Study completion31 Oct 2023
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodoros Foukakis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theodoros Foukakis, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322215
- Sponsor's protocol ID
- 2016-002893-11
- Other IDs
- 2016
- Acronym
- PASIPHAE
- Status last verified
- May 2023
- First submitted
- 28 Sep 2017
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance
- ClinicalTrials.gov ID
- NCT03322215
- Acronym / sponsor ID
- PASIPHAE / 2016-002893-11
- Conditions
- Breast Cancer Metastatic
- Keywords
- palbociclib, fulvestrant, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Theodoros FoukakisUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Oct 2017 (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.
This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included.
The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment.
Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib and fulvestrant | Experimental | Drug: Palbociclib, Drug: FulvestrantCombination of palbociclib and fulvestrant Palbociclib: 125 mg capsule administered orally once daily for 21 consecutive days followed by 7 days off treatment. Dose modification is recommended based on individual safety and tolerability. Fulvestrant: 500 mg administered intramuscularly on days 1 and 15 of cycle 1, and then on day 1 of each subsequent 28-day cycle. |
| Capecitabine | Active comparator | Drug: Capecitabine1,000 mg/m2 tablet administered orally twice daily for 2 weeks followed by one week of rest. Depending on adverse reactions, both dose escalation and dose reductions will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Women 18 years or older.
- Postmenopausal, defined by at least one of the following criteria:
- Locally advanced or metastatic breast cancer deemed not amenable to curative surgery or curative radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Known estrogen-receptor positive and/or progesterone receptor positive breast cancer reported by local laboratory.
Key exclusion criteria (19 listed)
- Previous treatment with a CDK4/6 inhibitor, mTOR or PI3K inhibitor, fulvestrant or capecitabine. Short-term (<28 days) exposure to mTOR or PI3K inhibitor in the (neo)adjuvant setting is allowed.
- More than one prior chemotherapy lines for metastatic breast cancer. Previous (neo)adjuvant chemotherapy or for radically treated local or regional relapse is allowed in addition to one prior chemotherapy line for metastatic breast cancer Note: A chemotherapy line in advanced disease is an anticancer regimen that contains at least one chemotherapy agent and is given for 21 days or longer. If a cytotoxic chemotherapy regimen was discontinued for a reason other than disease progression and the decision for its discontinuation was taken within 21 days after starting it, then this regimen does not count as a "prior line of chemotherapy". Chemotherapy regimens composed of more than one drug are considered as one line of therapy.
- No measurable lesions amenable to biopsy (e.g. pleural effusion, ascites, skin rash, sclerotic bone etc).
- CNS metastases unless asymptomatic and adequately controlled with surgery or radiotherapy. Stable CNS disease is defined as CNS metastases or cord compression that have been definitively treated and the patient is clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Leptomeningeal carcinomatosis
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 |
|---|---|---|
| PalbociclibAlso: Ibrance75-125 mg capsule orally once daily for 21 consecutive Days followed by 7 Days of treatment. | Drug | Palbociclib and fulvestrant |
| FulvestrantAlso: Faslodex500 mg intramuscularly Days 1 and 15 of cycle 1, and then on Day 1 of each subsequent 28-days cycle. | Drug | Palbociclib and fulvestrant |
| CapecitabineAlso: XelodaOral tablet 500 - 1,250 mg/m2 twice Daily, for 2 weeks followed by 1 week of rest. | Drug | Capecitabine |
Primary outcome
Progression free survival (PFS), as assessed locally by the investigator.
Time frame: Time from the date of randomization to the date of progression, assessed up to 5 years.
Time to progression will be measured according to the RECIST criteria (version 1.1). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and - together with other lesions that are denoted as non-target lesions - followed until disease progression.
15 secondary outcomes
Health related quality of life score EuroQol (EQ-5D)
Time frame: Baseline to progression up to 2 years
Health related quality of life score EORTC QLQ-C30
Time frame: Baseline to progression up to 2 years
Health related quality of life score EORTC QLQ-BR23
Time frame: Baseline to progression up to 2 years
Correlation of efficacy measures with tumor Biomarkers
Time frame: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years..
Correlation of efficacy measures with tumor Biomarkers
Time frame: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
Time frame: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
Time frame: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Correlation of efficacy measures with tumor Biomarkers
Time frame: Correlative analyses will be performed after the end of the trial. PFS is defined as time from the date of randomization to the date of progression assessed up to 5 years.
Overall survival (OS)
Time frame: Time from randomization to death from any cause, assessed up to 5 years.
1-year survival
Time frame: Time from randomization to death from any cause, assessed up to 5 years.
2-year survival
Time frame: Time from randomization to death from any cause, assessed up to 5 years.
Objective response
Time frame: From randomization until end of treatment, assessed up to 5 years.
Duration of response
Time frame: From randomization until end of treatment, up to 5 years.
Clinical Benefit Rate
Time frame: From randomization until end of treatment, up to 5 years.
Frequency of adverse events (AE)
Time frame: From randomization until 28 days after the last dose of study medication, assessed up to 5 years.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib, Fulvestrant and Capecitabine in people with Breast Cancer Metastatic, run by Theodoros Foukakis at 9 sites in 2 countries.
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 25 inclusion and 19 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: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS), as assessed locally by the investigator. (time frame: Time from the date of randomization to the date of progression, assessed up to 5 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 8 Mar 2024.