Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
180
Countries
1
Sites
3
Early breast cancer
Evaluate the impact of neoadjuvant endocrine treatment with palbociclib compared with standard chemotherapy on objective response and long- term outcome.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Dec 2014 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519019-32-00
- EudraCT number
- 2014-000810-72
- ClinicalTrials.gov
- NCT02603679
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenomic
Evaluate the impact of neoadjuvant endocrine treatment with palbociclib compared with standard chemotherapy on objective response and long-
term outcome.
Secondary objectives 1
- Identify tumor characteristics and treatment-related changes of tumor biology predictive of long-term prognosis
Conditions and MedDRA coding
Early breast cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Written informed consent
- Female or male patients with breast cancer confirmed by histology
- Tumor and blood samples available. Luminal type confirmed by immunohistochemistry with ER≥10 %, not not HER2 3+/amplified
- Age 35 years or older. Elderly patients in condition adequate for planned therapy.
- Primary breast cancer >20 mm in diameter and/or verified regional lymph node metastases
- Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
- ECOG performance status 0-1
- Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well- defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
Exclusion criteria 5
- Distant metastases, including node metastases in the 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
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment
Secondary endpoints 7
- Pathological objective response to primary medical treatment
- Sequencing of chemotherapy versus endocrine treatment plus palbociclib
- Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer
- Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS)
- Safety
- Quality of life
- Frequency of breast-conserving surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
IBRANCE 125 mg film-coated tablets
PRD7907865 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 5
PRD5889915 · Product
- Active substance
- Tamoxifen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA01 — TAMOXIFEN
- Marketing authorisation
- 44/0290/00-S
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- Slovakia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Letrozole Sandoz 2,5 mg filmdragerade tabletter
PRD747119 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 43311
- MA holder
- SANDOZ A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel Accord 6 mg/ml koncentrat till infusionsvätska, lösning
PRD373143 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 90 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 27782
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Exemestan Sandoz 25 mg, filmdragerade tabletter
PRD745964 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- 42037
- MA holder
- SANDOZ A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Anastrozol Sandoz 1 mg filmdragerade tabletter
PRD744781 · Product
- Active substance
- Anastrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- 25661
- MA holder
- SANDOZ A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Thomas Hatschek
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Thomas Hatschek
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 180 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2014-12-05 | 2016-03-18 | 2021-07-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519019-32-00 PREDIX LumB | 6.0 |
| Protocol (for publication) | D1_Protocol 2024-519019-32-00 PREDIX LumB ren | 7 |
| Protocol (for publication) | D1_Protocol 2024-519019-32-00 PREDIX LumB tc | 7 |
| Recruitment arrangements (for publication) | blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PREDIX-LumB | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF recurrence PREDIX-LumB | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Anastrozol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC EPAR Palbociclib en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Exemestan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Letrozol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociklib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tamoxifen | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-519019-32-00 PREDIX-LumB | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Sweden | Acceptable 2024-10-28
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-23 | Sweden | Acceptable 2025-09-01
|
2025-09-03 |