Breast CancerEarly Phase 1PROMETEO IINCT04130152
Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
A Early Phase 1 study testing Palbociclib and Letrozole in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 8 sites in Spain.
Trial summary
PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 8 sitesSpain
- Study dates
- 21 Nov 2019to 24 Feb 2022
- Phase
- Early Phase 1
- 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
- Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Female patients age ≥ 18 years.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 1.
- Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics:
- Breast cancer eligible for surgery.
- ER-positive and/or PgR-positive and HER2-negative tumor by the most recent ASCO/CAP guidelines, before neoadjuvant treatment locally assessed.
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- Ki67% ≥ 5% after neoadjuvant chemotherapy locally assessed (Dowsett M et al JNCI 2011).
- A lesion that could be confirmed by ultrasound (US) after neoadjuvant chemotherapy.
- Completed ≥80% total dose of an anthracycline/taxane-based neoadjuvant regimen planned. The allowed chemotherapy regimens will be AC (cyclophosphamide, doxorubicin) or EC (epirubicin, cyclophosphamide) 4 cycles followed by weekly paclitaxel x 12 or AC or EC 4 cycles followed by docetaxel 4 cycles. It would be acceptable to change the administration sequence to paclitaxel followed by AC/EC. AC can be given either a standard dose or in a dose-dense schedule. Paclitaxel could be administered as a solvent-based or Nanoparticle albumin-bound (Nab) formulation.
- Availability of a recent formalin-fixed paraffin-embedded (FFPE) tumor sample before NAC and a research tumor biopsy after NAC. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 μm each.
- Adequate organ function determined within 28 days prior to enrollment, defined as follows:
- Hematological
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL (red blood cell transfusion and/or erythropoietin allowed)
- Renal
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or 24-hour creatinine clearance ≥ 60 mL/min for a subject with creatinine levels >1.5 x ULN. (Note: Creatinine clearance does not need to be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard).
- Hepatic
- Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN Coagulation International normalization ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN
- Serum or urine pregnancy test must be negative within 7 days prior enrollment in women of childbearing potential. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential enrolled to the treatment must use adequate contraception for the duration of protocol treatment.
- Absence of 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.
- Resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
- Pre/peri-menopausal and post-menopausal women are allowed; menopausal status is relevant for the requirement of goserelin or triptorelin to be used concomitantly with palbociclib plus letrozole. Post-menopausal status is defined either by:
- Prior bilateral oophorectomy or
- Age ≥60 or
- Age < 60 and amenorrhea for ≥ 12 months prior to the start of neoadjuvant chemotherapy and FSH and estradiol in the post-menopausal range per local standards prior to the start of neoadjuvant chemotherapy.
- For patients who do not meet the one of the previous parameters, therapy-induced amenorrhea (goserelin or triptorelin), it must have been started more 14 days before the start of palbociclib plus letrozole treatment.
Who cannot join
- Non-operable, locally advanced breast cancer (inoperable stage III) after NAC.
- Bilateral or metastatic invasive breast cancer at the time of the diagnosis.
- Known severe hypersensitivity reactions to compounds similar to palbociclib or to excipients or to endocrine treatments.
- History of any previous treatment using Aromatase inhibitors (AI) o selective estrogen receptor modulator (SERMs) in the past 5 years.
- Prior therapy with palbociclib or any cyclin-dependent kinase (CDK) inhibitor.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to enrollment.
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- Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization.
- Any surgery (not including minor procedures such as primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
- Sentinel lymph node biopsy is not allowed before NAC.
- Diagnosis of any previous malignancy within the last 3 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
- Malabsorption syndrome or other condition that would interfere with enteric absorption.
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia).
- Any of the following within 6 months of enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
- Corrected QT interval (QTc) greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP).
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital General de Catalunya
Barcelona
ICO Hospitalet
Barcelona
Hospital 12 de octubre
Madrid
Hospital Universitario Infanta Sofía
Madrid
Hospital Virgen de la Victoria
Málaga
Hospital Son Espases
Palma de Mallorca
Complejo Hospitalario Santiago de Compostela (CHUS)
Santiago de Compostela
Hospital Virgen del Rocío
Seville
About this study
Official title: Palbociclib in Combination With Letrozole in Patients With Hormone Receptor (HR) Positive/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Residual Disease After Standard Neoadjuvant Chemotherapy (PROMETEO II)
PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection.
Read the detailed description
This is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable BC patients with residual disease after NAC and help to identify biomarkers for better patient selection.
The primary endpoint will be the Complete Cell Cycle Arrest (CCCA) determined by Ki67<2.7%, centrally assessed at surgery after 4 weeks of palbociclib and letrozole.
Tumor measurement will be performed by ultrasound (US) for disease evaluation and confirmation of residual disease will be performed at screening at the end of NAC. The biopsy after chemotherapy will only be done after confirmation of residual disease by US. Ki67% ≥ 5% after NAC by local determination will be necessary to be included in the study.
Patients will be administered palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle and letrozole: oral, 2.5 mg per day continuously, one cycle of treatment.
After the finalization of the neoadjuvant treatment, patients will undergo surgery. Surgery specimens will be collected for histological examination and biomarker analysis
The end of the study is defined as the date of post-surgery visit and will take place 4 weeks (+/- 7days) after the surgery in order to monitor the patient's safety and collect the surgery information.
- Conditions
- Breast Cancer
- Being tested
- Palbociclib, Letrozole
- Keywords
- Palbociclib, residual disease, Neoadjuvant treatment, Ki67
- Medical subject headings
- Breast Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle
LetrozoleDrug
Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib + Letrozole | Experimental | Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.
If the patient is pre-menopausal, ovarian suppression with luteinizing hormone-releasing hormone (LHRH) analogues (ie, triptorelin 3.75 mg intra-muscular (IM) or Goserelin 3,6 mg SC) must be initiated at least 2 weeks before palbociclib plus letrozole administration. Receives: Drug: Palbociclib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cell Cycle Arrest (CCCA)
Complete Cell Cycle Arrest (CCCA) determined by Ki67< 2.7% at surgery following treatment with palbociclib plus letrozole, by central laboratory
Measured: Ki67 will be determined at surgery by central laboratory
Secondary outcomes (4)
Residual Cancer Burden (RCB)
Changes in Ki67 between baseline samples (before NAC), residual disease samples after NAC and surgical samples following palbociclib with letrozole.
Measured: Pretreated sample before NAC, after NAC and at surgery 4 weeks after palbociclib and letrozole treatment
Residual Cancer Burden (RCB)
Rate of RCB score 0 or 1 (RCB 0/1) after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per local assessment
Measured: At surgery, 4 weeks after palbociclib and letrozole treatment
Pathological complete response (pCR)
Rate of pCR (ypT0/TisypN0) defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery, irrespective of in situ carcinoma in the breast and in the breast and axilla by local evaluation.
Measured: At surgery, 4 weeks after palbociclib and letrozole treatment
Incidence, duration and severity of Adverse Events (AEs)
Incidence and severity of treatment-emergent and treatment-related adverse events assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, including dose reductions, delays and treatment discontinuations.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start21 Nov 2019
- Primary completion26 Jan 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130152
- Sponsor's protocol ID
- SOLTI-1710
- Other IDs
- 2019-001275-36, 2019
- Acronym
- PROMETEO II
- Status last verified
- Jun 2022
- First submitted
- 14 Oct 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pernas S, Sanfeliu E, Villacampa G, Salvador J, Perello A, Gonzalez X, Jimenez B, Merino M, Palacios P, Pascual T, Alba E, Villanueva L, Chillara S, Ferrero-Cafiero JM, Galvan P, Prat A, Ciruelos E. Palbociclib and letrozole for hormone receptor-positive HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy. NPJ Breast Cancer. 2024 Nov 26;10(1):101. doi: 10.1038/s41523-024-00710-x.
PubMed 39592624
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palbociclib in Combination With Letrozole in Patients With Hormone Receptor (HR) Positive/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Residual Disease After Standard Neoadjuvant Chemotherapy (PROMETEO II)
- ClinicalTrials.gov ID
- NCT04130152
- Acronym / sponsor ID
- PROMETEO II / SOLTI-1710
- Conditions
- Breast Cancer
- Keywords
- Palbociclib, residual disease, Neoadjuvant treatment, Ki67
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 17 Oct 2019 (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.
PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection.
Detailed description
This is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable BC patients with residual disease after NAC and help to identify biomarkers for better patient selection.
The primary endpoint will be the Complete Cell Cycle Arrest (CCCA) determined by Ki67<2.7%, centrally assessed at surgery after 4 weeks of palbociclib and letrozole.
Tumor measurement will be performed by ultrasound (US) for disease evaluation and confirmation of residual disease will be performed at screening at the end of NAC. The biopsy after chemotherapy will only be done after confirmation of residual disease by US. Ki67% ≥ 5% after NAC by local determination will be necessary to be included in the study.
Patients will be administered palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle and letrozole: oral, 2.5 mg per day continuously, one cycle of treatment.
After the finalization of the neoadjuvant treatment, patients will undergo surgery. Surgery specimens will be collected for histological examination and biomarker analysis
The end of the study is defined as the date of post-surgery visit and will take place 4 weeks (+/- 7days) after the surgery in order to monitor the patient's safety and collect the surgery information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + Letrozole | Experimental | Drug: Palbociclib, Drug: LetrozolePalbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle. If the patient is pre-menopausal, ovarian suppression with luteinizing hormone-releasing hormone (LHRH) analogues (ie, triptorelin 3.75 mg intra-muscular (IM) or Goserelin 3,6 mg SC) must be initiated at least 2 weeks before palbociclib plus letrozole administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Female patients age ≥ 18 years.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 1.
- Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics:
- Completed ≥80% total dose of an anthracycline/taxane-based neoadjuvant regimen planned. The allowed chemotherapy regimens will be AC (cyclophosphamide, doxorubicin) or EC (epirubicin, cyclophosphamide) 4 cycles followed by weekly paclitaxel x 12 or AC or EC 4 cycles followed by docetaxel 4 cycles. It would be acceptable to change the administration sequence to paclitaxel followed by AC/EC. AC can be given either a standard dose or in a dose-dense schedule. Paclitaxel could be administered as a solvent-based or Nanoparticle albumin-bound (Nab) formulation.
Key exclusion criteria (16 listed)
- Non-operable, locally advanced breast cancer (inoperable stage III) after NAC.
- Bilateral or metastatic invasive breast cancer at the time of the diagnosis.
- Known severe hypersensitivity reactions to compounds similar to palbociclib or to excipients or to endocrine treatments.
- History of any previous treatment using Aromatase inhibitors (AI) o selective estrogen receptor modulator (SERMs) in the past 5 years.
- Prior therapy with palbociclib or any cyclin-dependent kinase (CDK) inhibitor.
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: IbrancePalbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle | Drug | Palbociclib + Letrozole |
| LetrozoleLetrozole: oral, 2.5 mg per day continuously. during the 28-day cycle. | Drug | Palbociclib + Letrozole |
Primary outcome
Complete Cell Cycle Arrest (CCCA)
Time frame: Ki67 will be determined at surgery by central laboratory
Complete Cell Cycle Arrest (CCCA) determined by Ki67< 2.7% at surgery following treatment with palbociclib plus letrozole, by central laboratory
4 secondary outcomes
Residual Cancer Burden (RCB)
Time frame: Pretreated sample before NAC, after NAC and at surgery 4 weeks after palbociclib and letrozole treatment
Residual Cancer Burden (RCB)
Time frame: At surgery, 4 weeks after palbociclib and letrozole treatment
Pathological complete response (pCR)
Time frame: At surgery, 4 weeks after palbociclib and letrozole treatment
Incidence, duration and severity of Adverse Events (AEs)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 39592624Pernas S, Sanfeliu E, Villacampa G, Salvador J, Perello A, Gonzalez X, Jimenez B, Merino M, Palacios P, Pascual T, Alba E, Villanueva L, Chillara S, Ferrero-Cafiero JM, Galvan P, Prat A, Ciruelos E. Palbociclib and letrozole for hormone receptor-positive HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy. NPJ Breast Cancer. 2024 Nov 26;10(1):101. doi: 10.1038/s41523-024-00710-x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Palbociclib and Letrozole in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 8 sites in Spain.
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 29 inclusion and 16 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: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete Cell Cycle Arrest (CCCA) (time frame: Ki67 will be determined at surgery by central laboratory). 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 NCT04130152, 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 25 Oct 2022.