Early-Stage Breast CarcinomaPhase 2PREDIX LumANCT02592083
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
A Phase 2 study testing Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin and Palbociclib in people with Early-Stage Breast Carcinoma and Hormone Receptor Positive Tumor, run by Thomas Hatschek at 1 site in Sweden.
Trial summary
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Early-Stage Breast Carcinoma, Hormone Receptor Positive Tumor
- What is being tested?
- Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin and Palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 41 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Female patients with non-lobular breast cancer confirmed by histology
- Tumor and blood samples available. Luminal A type confirmed by immunohistochemistry with ER and PR positive ≥50% and the proliferation marker Ki 67 <20% and not HER2 amplified
- Age older than 40 years
- Primary breast cancer >20mm without lymph node metastases
- Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
- LVEF >50%
- ECOG performance status 0-1
Who cannot join
- Metastases, including node metastases in the ipsilateral and/or contralateral thoracic region or in the mediastinum
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Age ≤40 years
- Lobular carcinoma
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Severe medical or psychiatric disorders where the study treatment or study procedures carry increased risk of deterioration of health status
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Oncology, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: PREDIX Luminal A - Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations.
Read the detailed description
Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women). Postmenopausal women receive an aromatase inhibitor.This treatment is given for 4 weeks. In cases with uncertain menopausal status (previous hysterectomy and equivocal gonadotropins), postmenopause age limit is defined as 55 years or older.
Ki67 is determined by FNA or core biopsy before start and after 2 weeks of treatment. After the initial 4-week period, patients with signs of response in terms of decrease of Ki67 by ≥20% are randomized to endocrine treatment either alone or in combination with the cdk 4/6 inhibitor palbociclib (arm A and B). Patients with tumors with stable disease, defined as <20% decrease or increase of Ki67 and without radiological indication of tumor progression at the 4-week evaluation are offered continuous endocrine treatment with the addition of palbociclib (arm C).
Dose regimen after 4 weeks of endocrine pretreatment:
Arm A: Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women). Postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 and 10 weeks of the preoperative treatment does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option.
Arm B: Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, if re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option.
Arm C: Treatment according to the schedule as described for arm B.
Postoperative chemotherapy is recommended to patients with either residual lymph node metastases >2mm (macro metastases) or primary tumor size >30mm in combination with Ki67>15%. Adjuvant endocrine treatment and radiotherapy is offered according to standard guidelines. Structured follow-up visits yearly for five years include reporting of persistent treatment-related toxicity, HRQoL, recurrence and death.
All patients are recommended adjuvant endocrine treatment for at least 5 years.
The trial contains also a translational subprotocol:
- PET-CT using FDG, confined to the chest, is performed before start of the first treatment period and after 10 weeks, i.e. 6 weeks after treatment allocation (functional imaging, optional).
- Core biopsies from the tumor are collected before start of the first treatment period and after 10 weeks, i.e. 6 weeks after treatment allocation. Further tissue samples are collected from the surgical specimen.
- Blood samples are collected repeatedly during the ongoing treatment and yearly follow-up.
- FNAs from metastases in case of recurrence during follow-up.
- Being tested
- Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin, Palbociclib
- Keywords
- Neoadjuvant Therapy, Cyclin-Dependent Kinase Inhibitor p16
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelinDrug
Also called Tamoxifen, Letrozol or Anastrozol or Exemestane, Zoladex
PalbociclibDrug
Also called Ibrance
| Study group | Role | What they receive |
|---|---|---|
| A: Endocrine treatment | Active comparator | Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option Receives: Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin |
| B: Endocrine treatment + palbociclib | Experimental | Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option Receives: Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin; Drug: Palbociclib |
| C: Endocrine treatment + palbociclib | Experimental | Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, if re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option Receives: Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiological Response
Clinical evaluations by use of calliper, radiological evaluations with mammography and ultrasound after 4, 10 and 16 weeks, PET-CT after 10 weeks of treatment, compared with baseline measurements
Measured: After 16 weeks of preoperative treatment
Secondary outcomes (10)
Pathological Evaluation of Tumor Response
Pathological signs of response, i.e. fibrosis, necrosis aso.
Measured: From date of surgery up to 4 weeks
Disease-free Survival
Disease-free survival includes all events related to breast cancer, and death from any cause during the follow-up period
Measured: From date of surgery until 60 months past surgery
Breast Cancer-specific Survival
Breast cancer-specific survival includes all events related to breast cancer and death caused by breast cancer during the follow-up period
Measured: From date of surgery until 60 months past surgery
Overall Survival
Overall survival relates to death from any cause during the follow-up period
Measured: From date of surgery until 60 months past surgery
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Safety will be assessed using NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) for reporting laboratory and non-laboratory toxicities.
Measured: From start of treatment until 28 days after termination of treatment. Delayed toxicity is reported until 60 months follow-up
Health-related Quality of Life
Measured: From start of study treatment until termination, and then annually during the 60 months of postoperative follow-up period
Biological characteristics of tumors exposed to targeted treatment of early breast cancer
Includes core biopsies and blood samples before start and after 10 weeks of treatment, collection of tumor samples from the surgical specimen at the date of operation, blood samples in connection with annual follow-up visits and FNA and blood samples in case of recurrence. Time frame for collection of biological samples from start of preoperative treatment until 60 months of follow-up post surgery. Planned analyses cover genomics (New Generation Sequencing) and proteomics
Measured: Before start and during treatment, at surgery, and then annually during the 60 months of postoperative follow-up period
Immunohistochemical characteristics
Includes core biopsies before start and after 10 weeks of treatment, and collection of tumor samples from the surgical specimen at surgery
Measured: Before start, during treatment and at the date of operation
Thymidine kinase (TK1) activity during study treatment
Includes repeated blood samples before start and after 4, 10 and 16 weeks of treatment
Measured: Before start and until termination of the preoperative treatment
Drug metabolism during study treatment
Includes repeated blood samples after 4 and 10 weeks of treatment with the aim to compare intra- and inter-patient metabolism of endocrine treatment in relation to response
Measured: Four and ten weeks after start of the preoperative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2019
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Breast CarcinomaStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hatschek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hatschek, Karolinska University Hospital
- Investigators
- Thomas Hatschek, Assoc. Prof., Study chair, Breast-sarcoma Unit, Dept. of Oncology, Karolinska University HospitalJonas Bergh, Professor, Study director, Dept. of Oncology-Pathology, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592083
- Sponsor's protocol ID
- PREDIX LumA
- Acronym
- PREDIX LumA
- Status last verified
- Jul 2020
- First submitted
- 26 Oct 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDIX Luminal A - Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
- ClinicalTrials.gov ID
- NCT02592083
- Acronym / sponsor ID
- PREDIX LumA / PREDIX LumA
- Keywords
- Neoadjuvant Therapy, Cyclin-Dependent Kinase Inhibitor p16
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Thomas HatschekUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- 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 purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations.
Detailed description
Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women). Postmenopausal women receive an aromatase inhibitor.This treatment is given for 4 weeks. In cases with uncertain menopausal status (previous hysterectomy and equivocal gonadotropins), postmenopause age limit is defined as 55 years or older.
Ki67 is determined by FNA or core biopsy before start and after 2 weeks of treatment. After the initial 4-week period, patients with signs of response in terms of decrease of Ki67 by ≥20% are randomized to endocrine treatment either alone or in combination with the cdk 4/6 inhibitor palbociclib (arm A and B). Patients with tumors with stable disease, defined as <20% decrease or increase of Ki67 and without radiological indication of tumor progression at the 4-week evaluation are offered continuous endocrine treatment with the addition of palbociclib (arm C).
Dose regimen after 4 weeks of endocrine pretreatment:
Arm A: Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women). Postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 and 10 weeks of the preoperative treatment does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option.
Arm B: Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, if re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option.
Arm C: Treatment according to the schedule as described for arm B.
Postoperative chemotherapy is recommended to patients with either residual lymph node metastases >2mm (macro metastases) or primary tumor size >30mm in combination with Ki67>15%. Adjuvant endocrine treatment and radiotherapy is offered according to standard guidelines. Structured follow-up visits yearly for five years include reporting of persistent treatment-related toxicity, HRQoL, recurrence and death.
All patients are recommended adjuvant endocrine treatment for at least 5 years.
The trial contains also a translational subprotocol:
- PET-CT using FDG, confined to the chest, is performed before start of the first treatment period and after 10 weeks, i.e. 6 weeks after treatment allocation (functional imaging, optional).
- Core biopsies from the tumor are collected before start of the first treatment period and after 10 weeks, i.e. 6 weeks after treatment allocation. Further tissue samples are collected from the surgical specimen.
- Blood samples are collected repeatedly during the ongoing treatment and yearly follow-up.
- FNAs from metastases in case of recurrence during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Endocrine treatment | Active comparator | Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelinPre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option |
| B: Endocrine treatment + palbociclib | Experimental | Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin, Drug: PalbociclibPatients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option |
| C: Endocrine treatment + palbociclib | Experimental | Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin, Drug: PalbociclibPatients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, if re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Female patients with non-lobular breast cancer confirmed by histology
- Tumor and blood samples available. Luminal A type confirmed by immunohistochemistry with ER and PR positive ≥50% and the proliferation marker Ki 67 <20% and not HER2 amplified
- Age older than 40 years
- Primary breast cancer >20mm without lymph node metastases
Key exclusion criteria (7 listed)
- Metastases, including node metastases in the ipsilateral and/or contralateral thoracic region or in the mediastinum
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Age ≤40 years
- Lobular carcinoma
- Patients in child-bearing age without adequate contraception
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 |
|---|---|---|
| Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelinAlso: Tamoxifen, Letrozol or Anastrozol or Exemestane, Zoladex | Drug | A: Endocrine treatment, B: Endocrine treatment + palbociclib, C: Endocrine treatment + palbociclib |
| PalbociclibAlso: Ibrance | Drug | B: Endocrine treatment + palbociclib, C: Endocrine treatment + palbociclib |
Primary outcome
Clinical and Radiological Response
Time frame: After 16 weeks of preoperative treatment
Clinical evaluations by use of calliper, radiological evaluations with mammography and ultrasound after 4, 10 and 16 weeks, PET-CT after 10 weeks of treatment, compared with baseline measurements
10 secondary outcomes
Pathological Evaluation of Tumor Response
Time frame: From date of surgery up to 4 weeks
Disease-free Survival
Time frame: From date of surgery until 60 months past surgery
Breast Cancer-specific Survival
Time frame: From date of surgery until 60 months past surgery
Overall Survival
Time frame: From date of surgery until 60 months past surgery
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time frame: From start of treatment until 28 days after termination of treatment. Delayed toxicity is reported until 60 months follow-up
Health-related Quality of Life
Time frame: From start of study treatment until termination, and then annually during the 60 months of postoperative follow-up period
Biological characteristics of tumors exposed to targeted treatment of early breast cancer
Time frame: Before start and during treatment, at surgery, and then annually during the 60 months of postoperative follow-up period
Immunohistochemical characteristics
Time frame: Before start, during treatment and at the date of operation
Thymidine kinase (TK1) activity during study treatment
Time frame: Before start and until termination of the preoperative treatment
Drug metabolism during study treatment
Time frame: Four and ten weeks after start of the preoperative treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
Thomas Hatschek, Assoc. Prof. study chair
Breast-sarcoma Unit, Dept. of Oncology, Karolinska University Hospital
Jonas Bergh, Professor study director
Dept. of Oncology-Pathology, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin and Palbociclib in people with Early-Stage Breast Carcinoma and Hormone Receptor Positive Tumor, run by Thomas Hatschek at 1 site in Sweden.
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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2020. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical and Radiological Response (time frame: After 16 weeks of preoperative treatment). 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 7 Jul 2020.