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Early-Stage Breast CarcinomaPhase 2PREDIX LumBNCT02603679

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

A Phase 2 study testing Paclitaxel, Tamoxifen + Palbociclib and Aromatase Inhibitor + Palbociclib in people with Early-Stage Breast Carcinoma and Estrogen Receptor Positive Tumor, run by Thomas Hatschek at 3 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel, Tamoxifen + Palbociclib and Aromatase Inhibitor + Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
3 sitesSweden
Study dates
Feb 2015to 31 Dec 2031
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Female or male patients with breast cancer confirmed by histology
  • Tumor and blood samples available. Luminal B type confirmed by immunohistochemistry or, preferably, genomic profiling using Next-Generation Sequencingwith ER ≥120% and Ki67 ≥20% and not HER2 amplified, or, if aged 40 or younger and/or verified lymph node metastases, luminal A type, defined as ER and PR positive ≥20% and the proliferation marker Ki 67 <20% and not HER2 amplified. Any luminal B, Luminal A with verified lymph node metastases and/or aged 40 or younger
  • Age 18 years or older. Elderly patients in condition adequate for planned therapy
  • Primary breast cancer >20mm 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
Show all 9Show fewer
  • LVEF >55%
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Södersjukhuset

    Stockholm, 11883

  • Karolinska University Hospital

    Stockholm, 17176

  • Capio S:t Göran Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: PREDIX Luminal B - Neoadjuvant Response-guided Treatment of ER Positive Tumors With High Proliferation or Low Proliferation With Metastatic Nodes. 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 chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-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. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

Read the detailed description

Patients are randomized to either weekly treatment with paclitaxel (arm A) or endocrine treatment in combination with palbociclib (arm B) for 12 weeks. Choice of endocrine treatment is for pre- and perimenopausal women and all men tamoxifen 20 mg daily, alternatively for women in this age cohort, an LHRH analogue in combination with an aromatase inhibitor, for all postmenopausal women treatment with an aromatase inhibitor. The aromatase inhibitors to be used according to local practice are anastrozole 1 mg daily, exemestane 25 mg daily, or letrozole 2.5 mg daily. Pre- or perimenopausal women and all men are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women). Postmenopausal women receive an aromatase inhibitor.

After 12 weeks, patients without signs of disease progression (PD) are switched to either endocrine treatment in combination with palbociclib (arm A) or weekly treatment with paclitaxel (arm B) for 12 weeks. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

Before start, after 6, 12, 18 and 24 weeks of treatment, radiological assessments of tumor size are performed using mammography and ultrasound alt. MRI breast; PET-CT, confined to the breast and regional lymph nodes, before start, after 12 and 24 weeks, blood tests before start, after 1 week, 12, 18 and 24 weeks. Physical examinations are performed before start and then four-weekly after weeks 4, 8, 12, 16, 20 and 24 weeks of treatment.

In case of disease progression during ongoing study treatment, individualized management in the patient's best interest must be considered, in which case surgery is the primary option.

Being tested
Paclitaxel, Tamoxifen + Palbociclib, Aromatase Inhibitor + Palbociclib, Goserelin + Aromatase Inhibitor + Palbociclib
Keywords
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.

  • PaclitaxelDrug

    Any brand of paclitaxel may be used, excluding nab-paclitaxel

  • Tamoxifen + PalbociclibDrug

    Also called Tamoxifen, Ibrance

    Any brand of tamoxifen may be used

  • Aromatase Inhibitor + PalbociclibDrug

    Also called Letrozole, Anastrozole, Exemestane, Ibrance

    Any brand of letrozole, anastrozole or exemestane may be used

  • Goserelin + Aromatase Inhibitor + PalbociclibDrug

    Also called Zoladex, Letrozole, Anastrozole, Exemestane

    Any brand of letrozole, anastrozole or exemestane may be used

Study groups in NCT02603679
Study groupRoleWhat they receive
A: Weekly PaclitaxelActive comparatorPatients receive weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for a 12-week period. Thereafter, treatment is switched to endocrine treatment in combination with palbociclib. Pre- or perimenopausal women and all men are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during the second 12-week period
Receives: Drug: Paclitaxel
B: Tamoxifen + PalbociclibExperimentalPre- or perimenopausal women and all men are treated with tamoxifen together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during a 12-week period. Thereafter, treatment is switched to weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for further 12 weeks.
Receives: Drug: Tamoxifen + Palbociclib
B: Aromatase Inhibitor + PalbociclibExperimentalPostmenopausal women receive an aromatase inhibitor together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during a 12-week period. Thereafter, treatment is switched to weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for further 12 weeks.
Receives: Drug: Aromatase Inhibitor + Palbociclib
B: Goserelin + Aromatase Inhibitor + PalbociclibExperimentalPre- or perimenopausal women may be treated with goserelin and an aromatase inhibitor together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during a 12-week period. Thereafter, treatment is switched to weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for further 12 weeks.
Receives: Drug: Goserelin + Aromatase Inhibitor + Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological Objective Response Rate after Completion of the First 12-week Period of Primary Medical Treatment

    Radiological response by use of mammography and ultrasound, alternatively MRI of the breast, if mammography/ultrasound does not allow for objective measurements of the primary tumor. Clinical measurements using calliper, if the tumor is palpable and tumor size cannot be estimated by radiological methods

    Measured: Start of treatment until 12 weeks of treatment

Secondary outcomes (12)

  1. Pathological Objective Response Rate

    Presence/abscense of residual tumor in mm, fibrosis and other signs of response by histology

    Measured: From the date of surgery up to 4 weeks after surgery

  2. Sequencing of Chemotherapy versus Endocrine Treatment plus Palbociclib in relation to Radiological Objective Response Rate after Completion of the 24-week Period of Primary Medical Treatment

    Radiological response by use of mammography and ultrasound, alternatively MRI of the breast, if mammography/ultrasound does not allow for objective measurements of the primary tumor. Clinical measurements using calliper, if the tumor is palpable and tumor size cannot be estimated by radiological methods

    Measured: From start of treatment until termination of the preoperative treatment after 24 weeks

  3. 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 10 years past surgery

  4. 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 10 years past surgery

  5. Overall Survival

    Overall survival relates to death from any cause during the follow-up period

    Measured: From date of surgery until 10 years past surgery

  6. 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 24 weeks of treatment. Delayed toxicity is reported until 60 months follow-up

  7. Health-Related Quality of Life

    Measured: From start of study treatment until termination after 24 weeks, and then annually during 5 years of postoperative follow-up period

  8. Frequency of Breast-Conserving Surgery

    Refers to the rate of patients who are operated with breast-conserving surgery compared with mastectomy

    Measured: At surgery after neoadjuvant therapy

  9. Characteristics of the Genome of Previously Untreated Tumors Before and After Exposition to Treatment

    New Generation Sequencing (NGS) is performed on biopsies from the tumors with the aim to classify the tumors according to PAM50. Repeated analyses of tumor tissue during the treatment process will be performed to identify heterogeneity and mutations which might be responsible for resistance to study treatment. Blood samples are collected to identify tumor DNA sequences which might predict recurrence during the follow-up period. Tissue and blood samples are also analyzed in case of recurrence. The results are descriptive and expressed as clustering. Units of measure are lacking

    Measured: Before start and during treatment, at surgery, and then annually during the 60 months of postoperative follow-up period

  10. Changes of the Proteome of Previously Untreated Tumors Before and After Exposition to Treatment

    Proteome analyses with the intention to identify tumor-specific pathways are performed on repeated biopsies from the tumors. The results are descriptive, defined units of measure are lacking

    Measured: Before start, during treatment and at surgery

  11. Quantification of Hormone Receptors Before and After Treatment

    Immunohistochemistry on core biopsies before start, after 10 weeks of treatment, and tumor samples from the surgical specimen. Presence of estrogen receptor (ER) and progesterone receptor (PR), described as percentage in relation to the total count of tumor cells

    Measured: Before start, during treatment and at surgery

  12. Quantification of Proliferation Before and After Treatment

    Immunohistochemistry on core biopsies before start, after 10 weeks of treatment, and tumor samples from the surgical specimen. Presence of cells indicating proliferation by use of Ki67, described as percentage in relation to the total count of tumor cells

    Measured: Before start, during treatment and at surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion30 Jul 2021
  4. Study completion31 Dec 2031 (estimated)

Resources

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
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603679
Sponsor's protocol ID
PREDIX LumB
Acronym
PREDIX LumB
Status last verified
Jul 2021
First submitted
4 Nov 2015
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Matikas A, Tzoras E, Sarafidis M, Sifakis EG, Bjohle J, Barnekow E, Margolin S, Isaksson-Friman E, Kessler LE, Zouzos A, Johansson H, Hellstrom M, Agartz S, Gryback P, Salgkamis D, Zerdes I, Wang K, Hartman J, Acs B, Sun W, Boyaci C, Villacampa G, Pascual T, Gavila J, Prat A, Perou C, Brandberg Y, Bergh J, Hatschek T, Foukakis T. Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. Nat Commun. 2026 Apr 8;17(1):3403. doi: 10.1038/s41467-026-71452-6.

    PubMed 41951647

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Tamoxifen + Palbociclib and Aromatase Inhibitor + Palbociclib in people with Early-Stage Breast Carcinoma and Estrogen Receptor Positive Tumor, run by Thomas Hatschek at 3 sites 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 9 inclusion and 5 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Radiological Objective Response Rate after Completion of the First 12-week Period of Primary Medical Treatment (time frame: Start of treatment until 12 weeks of treatment). 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 NCT02603679, which also lists 1 linked publication.

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 3 Aug 2021.

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