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Tests treatment safety and results for Hormonal Receptors Positive, HER2 Negative, Advanced...
Official title Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.
ClinicalTrials.gov ID: NCT05190094
What this study is testing
What is Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole)?
Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole) is an investigational medicine, given as an once-daily, being studied as a potential treatment for hormonal receptors positive, her2 negative, advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, international, open-label phase II study. Based on inclusion/exclusion criteria, eligible pre and postmenopausal patients with newly diagnosed metastatic luminal hormone receptor-positive and HER2 negative breast cancer, will be prospectively treated with a standard combination of hormone therapy (Letrozole or Anastrozole) and Palbociclib.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- To be enrolled in the study, patients should meet the following
- Written informed consent before beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up...
- Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH.
- Performance status \< 3 (according to WHO criteria).
- Histologically confirmed breast cancer (Luminal A or B).
You likely can't join if
- To be enrolled in the study, patients should meet the following exclusion criteria:
- Male patients.
- HER2 positive tumors or unknown HR/HER2 status.
- Triple-negative Breast Cancer (ER\<1%).
- Pregnant or breast-feeding women, or those who plan to become pregnant within 6 months post-treatment.
- No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post-treatment.
See the full eligibility criteria
- To be enrolled in the study, patients should meet the following
- Written informed consent before beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the local regulatory...
- Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH.
- Performance status \< 3 (according to WHO criteria).
- Histologically confirmed breast cancer (Luminal A or B).
- Estrogen Receptor positive (ER \> 1%).
- HER2 negative (score 0 or 1 by immunochemistry), FISH negative if IHC score 2.
- Clinical stage IIIb \& IV.
- Either:
- Women with De novo advanced luminal HER2 negative advanced breast cancer without other prior systemic treatment for advanced disease.
- Women with luminal HER2 negative advanced breast cancer either with secondary resistance (relapse after 2 years of adjuvant hormone therapy or within 12 months of completion of adjuvant HT) or sensitivity to adjuvant HT...
- Measurable or evaluable disease.
- Hematology:
- Neutrophil count ≥ 1.5 G/L,
- Platelet count ≥ 100 G/L,
- Leucocyte count \> 3.0 G/L,
- Hb\> 9g/dl.
- Hepatic function:
- Total bilirubin ≤ 1.5 times the upper normal limit (UNL),
- ASAT ≤ 2.5xUNL,
- ALAT ≤ 2.5xUNL,
- Alkaline phosphatase ≤ 2.5 times the upper normal limit (UNL).
- Renal function:
- Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, creatinine clearance ≥40 mL/min),
- Metabolic function:
- Serum calcium ≥ lower limit of normal.
- Negative pregnancy test (urine or serum) within 7 days before registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during...
- Patients with negative Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results.
- To be enrolled in the study, patients should meet the following exclusion criteria:
- Male patients.
- HER2 positive tumors or unknown HR/HER2 status.
- Triple-negative Breast Cancer (ER\<1%).
- Pregnant or breast-feeding women, or those who plan to become pregnant within 6 months post-treatment.
- No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post-treatment.
- Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or loco-regional disease (stages I, II \& IIIa).
- Non-evaluable tumor.
- Bilateral breast cancer.
- Patients with a history of other cancer, except in situ cervical cancer or baso-cellular skin cancer, considered cured.
- Patient has another disease, which is deemed incompatible with the inclusion in the protocol.
- Heart, kidney, medullary, respiratory or liver failure.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) at baseline.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease at baseline,
- Acute urinary infection, ongoing hemorrhagic cystitis at baseline.
- Uncontrolled diabetes.
- Symptomatic or progressive disorder of the central nervous system (CNS) at baseline.
- Patients with positive Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results.
- Significant psychiatric abnormalities.
- History of hypersensitivity to studied treatment or excipients.
- Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
- Any investigational agent within 30 days before initiation of study treatment.
- Patient unwilling or unable to comply with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Blida, Algeria
- Sétif, Algeria
- Amman, Jordan
- Riyadh, Saudi Arabia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blida, Algeria; Sétif, Algeria; Amman, Jordan; Riyadh, Saudi Arabia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.