Breast NeoplasmPhase 4PRECYCLENCT03220178
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
A Phase 4 study testing Palbociclib, Fulvestrant and Anastrozole in people with Breast Neoplasm, run by Palleos Healthcare GmbH at 1 site in Germany.
Trial summary
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Palbociclib, Fulvestrant and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2017to 7 Dec 2021
- Phase
- Phase 4
- 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
- Post- or pre/peri-menopausal female patients, age ≥18 years
- Patients with metastatic or locally advanced (non-operable) breast cancer disease
- Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination therapy OR Patients having already received endocrine therapy who are appropriate candidates for fulvestrant+ palbociclib combination therapy
- Patient has not received treatment for locally advanced or metastatic disease OR Patient has received one prior line of chemotherapy and/or a maximum of two endocrine therapy lines for locally advanced or metastatic disease
- Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
- The tumor must be hormone-receptor positive
Show all 14Show fewer
- The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization..
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ and marrow function before palbociclib treatment starts on C1D.
- In case of patients of child bearing potential: negative pregnancy test (urine or serum) at baseline. Patients must agree to use highly effective non-hormonal contraception
- Resolution of all acute toxic effects of prior therapy, including radiotherapy grade <1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
- Signed Written Informed Consent
- Willingness and capability to use CANKADO
- Availability of hardware: Computer and/or tablet and/or smartphone with internet access
Who cannot join
- Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its excipients
- Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists (if pre-menopausal)
- Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
- Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term
- Known active uncontrolled or symptomatic central nervous system metastases
- Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4)
Show all 14Show fewer
- High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months of enrollment
- Diagnosis of any second malignancy within the last 5 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Participation in other clinical trials involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation
- Lactating women
- Life expectancy < 3 months
- Known infection with HIV, hepatitis B virus, or hepatitis C virus
- Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
- Legal incapacity or limited legal capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.
Read the detailed description
This is a multicenter (80 sites) , randomized, parallel-group, Phase IV clinical trial with the primary objective of testing the hypothesis of superiority for time to deterioration (TTD) in patients using the ePRO system CANKADO active over CANKADO inform version.
Eligible patients will have histologically or cytologically proven diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)- negative locally advanced or metastatic breast cancer and will be either candidates to receive palbociclib in combination with aromatase inhibitor or candidates to receive palbociclib in combination with fulvestrant for their locally advanced or metastatic disease. Patients who are candidates for palbociclib in combination with aromatase inhibitor (AI) or fulvestrant will not be candidates for curative therapies. For Patients who are candidates for palbociclib in combination with aromatase inhibitor or fulvestrant one prior line of chemotherapy for locally advanced or metastatic breast cancer is allowed in addition to a maximum of two lines of endocrine therapy. Patients will be stratified according their eligibility of receiving palbociclib with endocrine therapy (AI or fulvestrant) as first or later lines.
Patients allocated to the combination of palbociclib with aromatase inhibitor will receive:
- Palbociclib, 125 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
- Aromatase inhibitor, orally once-daily (continuously).
- Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon (GnRH)-agonist
Patients allocated to the combination of palbociclib with fulvestrant will receive:
- Palbociclib, 125 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
- Fulvestrant , 500 mg, intramuscularly on Days 1 and 14 of Cycle 1, every 28 days (± 7 days) thereafter starting.
- Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon (GnRH)-agonist
Patients of each treatment group (palbociclib / aromatase inhibitor and palbociclib/fulvestrant) will randomized 2:1 in the Intervention Arm A CANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome (HDOB-PRO).
And in the Control Arm B CANKADO inform stands for a CANKADO-based eHealth service with a personal login. On-site surveys without feedback functions for the patient will be available. CANKADO inform will be used for the initial ePRO and further on-site ePROs. Patients can login from at home and can document their drug intake. Further features will not be available.
Patients will continue to receive study treatment together with the assigned ePRO assessment until investigator assessed disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. In addition, should palbociclib related toxicity mandate discontinuation; patients can continue to receive fulvestrant alone.
Patients discontinuing the active treatment phase will enter a follow-up period phase during survival further progression and new anti-cancer therapy information will be collected once a year up to 48 month after randomization.
In addition biomarkers will be assessed as a scientific program within this study. Tumor material (tumor tissue and Blood samples (plasma and serum)) will be collected. Tumor tissue from available primary tumor and available biopsies from recurrent disease will be collected. Blood samples will be collected at four time points (cycle 1 (C1D1), after 2 weeks (C1D14), after 12 weeks (C4D1), and upon progression (End of treatment).
- Conditions
- Breast Neoplasm
- Being tested
- Palbociclib, Fulvestrant, Anastrozole, Letrozole, Exemestane
- Keywords
- breast cancer, HER2 negative, hormone receptor positive, advanced, metastatic
- 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.
PalbociclibDrug
Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle
FulvestrantDrug
500mg per use-after first application, again at wk2, then once per month
AnastrozoleDrug
1mg per day
LetrozoleDrug
2,5mg/day
ExemestaneDrug
25mg/day
| Study group | Role | What they receive |
|---|---|---|
| CANKADO active | Experimental | CANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome. Receives: Drug: Palbociclib; Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane |
| CANKADO inform | Other | CANKADO inform stands for a CANKADO-based eHealth service with a personal login. For the patient , on-site surveys without feedback functions and a dosing tracker to document daily drug intake will be available. CANKADO inform will be used for the initial ePRO and further on-site ePROs. Patients can login from home, but they will only get text information about their disease and treatment. Further features will be unavailable. Receives: Drug: Palbociclib; Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
DQoL
The event "deterioration of quality of life" (DQoL) will be measured every 28 days after enrolment using the FACT-B scale.
Measured: From start of study treatment up to 4 years
Secondary outcomes (4)
Progression-free survival
Progression-free survival (PFS) is considered to be the main clinical outcome and is defined as the time between treatment allocation and either first documentation of objective progression of disease (PD), as assessed by Investigator or death due to any cause in absence of PD.
Measured: From start of study treatment up to 4 years
Overall survival
Overall survival (OS) is defined as the time between treatment allocation and death due to any cause.
Measured: From start of study treatment up to 4 years
Drug intake
Daily electronic documentation of dosage and time of drug intake.
Measured: From start of study treatment up to 4 years
Global health status
Daily electronic rating of overall health-related quality of life on a visual analogue scale (EQ-VAS) between 100 (best health imaginable) and 0 (worst health imaginable).
Measured: From start of study treatment up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start24 Jul 2017
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Why it stopped: Due to COVID-19 pandemic, study cannot be finished in planned timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palleos Healthcare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WSG WOMEN´S HEALTHCARE STUDY GROUP, Cankado GmbH, Pfizer, AGO-TraFo, AGO-B, Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.
- Responsible party
- Sponsor
- Investigators
- Iris Reiser, PhD, Study director, Palleos Healthcare GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220178
- Sponsor's protocol ID
- PH001-PreCycle
- Acronym
- PRECYCLE
- Status last verified
- Dec 2021
- First submitted
- 6 Jul 2017
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.
PubMed 14627058Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002 May;11(3):207-21. doi: 10.1023/a:1015276414526.
PubMed 12074259Cobos B, Haskard-Zolnierek K, Howard K. White coat hypertension: improving the patient-health care practitioner relationship. Psychol Res Behav Manag. 2015 May 2;8:133-41. doi: 10.2147/PRBM.S61192. eCollection 2015.
PubMed 25999772Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.
PubMed 19900250de Rond ME, de Wit R, van Dam FS, Muller MJ. A pain monitoring program for nurses: effects on communication, assessment and documentation of patients' pain. J Pain Symptom Manage. 2000 Dec;20(6):424-39. doi: 10.1016/s0885-3924(00)00209-8.
PubMed 11131261Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
PubMed 22145124Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027.
PubMed 12479768Dorand RD, Nthale J, Myers JT, Barkauskas DS, Avril S, Chirieleison SM, Pareek TK, Abbott DW, Stearns DS, Letterio JJ, Huang AY, Petrosiute A. Cdk5 disruption attenuates tumor PD-L1 expression and promotes antitumor immunity. Science. 2016 Jul 22;353(6297):399-403. doi: 10.1126/science.aae0477. Epub 2016 Jul 21.
PubMed 27463676Eton DT, Cella D, Yost KJ, Yount SE, Peterman AH, Neuberg DS, Sledge GW, Wood WC. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004 Sep;57(9):898-910. doi: 10.1016/j.jclinepi.2004.01.012.
PubMed 15504633Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.
PubMed 25524798Finn RS, Martin M, Rugo HS, Jones SE, Im SA, Gelmon KA, Harbeck N, Lipatov ON, Walshe JM, Moulder SL, Gauthier ER, Lu D, Randolph S, Diéras V, Slamon DJ. PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in post-menopausal women with ER+/HER2- advanced breast cancer (ABC). J Clin Oncol 34, 2016 (suppl; abstr 507)
Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
PubMed 27959613Harbeck, N., R. Wuerstlein and T. Schinkoethe (2015).
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79.
PubMed 17034633
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant
- ClinicalTrials.gov ID
- NCT03220178
- Acronym / sponsor ID
- PRECYCLE / PH001-PreCycle
- Conditions
- Breast Neoplasm
- Keywords
- breast cancer, HER2 negative, hormone receptor positive, advanced, metastatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 pandemic, study cannot be finished in planned timeframe.
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Palleos Healthcare GmbHIndustry (pharma, biotech, devices)
- Collaborators
- WSG WOMEN´S HEALTHCARE STUDY GROUP, Cankado GmbH, Pfizer, AGO-TraFo, AGO-B, Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 18 Jul 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.
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.
Detailed description
This is a multicenter (80 sites) , randomized, parallel-group, Phase IV clinical trial with the primary objective of testing the hypothesis of superiority for time to deterioration (TTD) in patients using the ePRO system CANKADO active over CANKADO inform version.
Eligible patients will have histologically or cytologically proven diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)- negative locally advanced or metastatic breast cancer and will be either candidates to receive palbociclib in combination with aromatase inhibitor or candidates to receive palbociclib in combination with fulvestrant for their locally advanced or metastatic disease. Patients who are candidates for palbociclib in combination with aromatase inhibitor (AI) or fulvestrant will not be candidates for curative therapies. For Patients who are candidates for palbociclib in combination with aromatase inhibitor or fulvestrant one prior line of chemotherapy for locally advanced or metastatic breast cancer is allowed in addition to a maximum of two lines of endocrine therapy. Patients will be stratified according their eligibility of receiving palbociclib with endocrine therapy (AI or fulvestrant) as first or later lines.
Patients allocated to the combination of palbociclib with aromatase inhibitor will receive:
- Palbociclib, 125 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
- Aromatase inhibitor, orally once-daily (continuously).
- Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon (GnRH)-agonist
Patients allocated to the combination of palbociclib with fulvestrant will receive:
- Palbociclib, 125 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment and
- Fulvestrant , 500 mg, intramuscularly on Days 1 and 14 of Cycle 1, every 28 days (± 7 days) thereafter starting.
- Pre- or peri-menopausal patients should additionally receive a Gonadotropin-Releasing-Hormon (GnRH)-agonist
Patients of each treatment group (palbociclib / aromatase inhibitor and palbociclib/fulvestrant) will randomized 2:1 in the Intervention Arm A CANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome (HDOB-PRO).
And in the Control Arm B CANKADO inform stands for a CANKADO-based eHealth service with a personal login. On-site surveys without feedback functions for the patient will be available. CANKADO inform will be used for the initial ePRO and further on-site ePROs. Patients can login from at home and can document their drug intake. Further features will not be available.
Patients will continue to receive study treatment together with the assigned ePRO assessment until investigator assessed disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. In addition, should palbociclib related toxicity mandate discontinuation; patients can continue to receive fulvestrant alone.
Patients discontinuing the active treatment phase will enter a follow-up period phase during survival further progression and new anti-cancer therapy information will be collected once a year up to 48 month after randomization.
In addition biomarkers will be assessed as a scientific program within this study. Tumor material (tumor tissue and Blood samples (plasma and serum)) will be collected. Tumor tissue from available primary tumor and available biopsies from recurrent disease will be collected. Blood samples will be collected at four time points (cycle 1 (C1D1), after 2 weeks (C1D14), after 12 weeks (C4D1), and upon progression (End of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CANKADO active | Experimental | Drug: Palbociclib, Drug: Fulvestrant, Drug: Anastrozole, Drug: Letrozole, Drug: ExemestaneCANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome. |
| CANKADO inform | Other | Drug: Palbociclib, Drug: Fulvestrant, Drug: Anastrozole, Drug: Letrozole, Drug: ExemestaneCANKADO inform stands for a CANKADO-based eHealth service with a personal login. For the patient , on-site surveys without feedback functions and a dosing tracker to document daily drug intake will be available. CANKADO inform will be used for the initial ePRO and further on-site ePROs. Patients can login from home, but they will only get text information about their disease and treatment. Further features will be unavailable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Post- or pre/peri-menopausal female patients, age ≥18 years
- Patients with metastatic or locally advanced (non-operable) breast cancer disease
- Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination therapy OR Patients having already received endocrine therapy who are appropriate candidates for fulvestrant+ palbociclib combination therapy
- Patient has not received treatment for locally advanced or metastatic disease OR Patient has received one prior line of chemotherapy and/or a maximum of two endocrine therapy lines for locally advanced or metastatic disease
- Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
Key exclusion criteria (14 listed)
- Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its excipients
- Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists (if pre-menopausal)
- Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
- Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term
- Known active uncontrolled or symptomatic central nervous system metastases
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 |
|---|---|---|
| PalbociclibPalbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle | Drug | CANKADO active, CANKADO inform |
| Fulvestrant500mg per use-after first application, again at wk2, then once per month | Drug | CANKADO active, CANKADO inform |
| Anastrozole1mg per day | Drug | CANKADO active, CANKADO inform |
| Letrozole2,5mg/day | Drug | CANKADO active, CANKADO inform |
| Exemestane25mg/day | Drug | CANKADO active, CANKADO inform |
Primary outcome
DQoL
Time frame: From start of study treatment up to 4 years
The event "deterioration of quality of life" (DQoL) will be measured every 28 days after enrolment using the FACT-B scale.
4 secondary outcomes
Progression-free survival
Time frame: From start of study treatment up to 4 years
Overall survival
Time frame: From start of study treatment up to 4 years
Drug intake
Time frame: From start of study treatment up to 4 years
Global health status
Time frame: From start of study treatment up to 4 years
Results and safety
The study was stopped early (reason given: Due to COVID-19 pandemic, study cannot be finished in planned timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Background: PubMed 14627058Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.
- Background: PubMed 9060536Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
- Background: PubMed 12074259Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002 May;11(3):207-21. doi: 10.1023/a:1015276414526.
- Background: PubMed 25999772Cobos B, Haskard-Zolnierek K, Howard K. White coat hypertension: improving the patient-health care practitioner relationship. Psychol Res Behav Manag. 2015 May 2;8:133-41. doi: 10.2147/PRBM.S61192. eCollection 2015.
- Background: PubMed 19900250Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.
- Background: PubMed 11131261de Rond ME, de Wit R, van Dam FS, Muller MJ. A pain monitoring program for nurses: effects on communication, assessment and documentation of patients' pain. J Pain Symptom Manage. 2000 Dec;20(6):424-39. doi: 10.1016/s0885-3924(00)00209-8.
- Background: PubMed 22145124Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
- Background: PubMed 12479768Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027.
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- Individual participant dataSharing planned: No
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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.
Iris Reiser, PhD study director
Palleos Healthcare GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palbociclib, Fulvestrant and Anastrozole in people with Breast Neoplasm, run by Palleos Healthcare GmbH at 1 site in Germany.
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 14 inclusion and 14 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 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Due to COVID-19 pandemic, study cannot be finished in planned timeframe.). 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?
DQoL (time frame: From start of study treatment up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03220178, which also lists 27 linked publications.
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 6 Jan 2022.