Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of ribociclib with drug combination in early breast cancer patients to test de‑escalated treatment strategies

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on early breast cancer, including the subtypes known as TNBC, HER2+, HR+ and HER2‑. Its purpose is to evaluate whether a response‑adapted de‑escalated neoadjuvant approach can achieve a complete disappearance of detectable cancer cells (pCR) and to assess risk‑adapted therapy based on genomic risk categories such as OncotypeDX.

Participants receive a combination of oral and infused medicines that may include ribociclib, tamoxifen citrate, capecitabine, exemestane, letrozole, docetaxel, epirubicin hydrochloride, anastrozole, pembrolizumab, trastuzumab, paclitaxel, pertuzumab, carboplatin, trastuzumab emtansine, abemaciclib and cyclophosphamide monohydrate. Before and after treatment, imaging with MRI and a small tissue sample taken by image‑guided biopsy are used to check for any remaining disease, and a laboratory marker called KI67 is measured to see how the tumor is responding.

The trial begins with screening visits, followed by several cycles of the assigned medicines over a few months, after which surgery is performed. Patients are then monitored regularly for up to several years to record whether the cancer returns, to track overall health and survival, and to collect information on side effects and quality of life using simple questionnaires.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After you are enrolled, you will undergo a series of baseline tests that include a physical examination, blood tests, breast mri, and a confirmatory image‑guided biopsy to determine the current status of the cancer.

    These assessments provide the information needed to assign you to the appropriate treatment arm and to record the initial ki67 level, which is a marker of tumor activity.

  2. Step 2

    Start oral medication regimen

    You will begin taking several oral tablets as prescribed by the study protocol:

    kisqali 200 mg film‑coated tablet: 200 mg taken once daily.

    xeloda 150 mg film‑coated tablet: dose expressed as 2500 mg/m2; you will take the amount calculated for your body surface area each day.

    exemestane 25 mg film‑coated tablet: 25 mg taken once daily.

    letrozole 2.5 mg film‑coated tablet: 2.5 mg taken once daily.

    arimidex 1 mg film‑coated tablet: 1 mg taken once daily.

    verzenios 150 mg film‑coated tablet: 300 mg total per day, which usually corresponds to two tablets taken together.

    tamoxifene‑ratiopharm 20 mg film‑coated tablet: 20 mg taken once daily.

    The exact number of days you will take each tablet is defined by the trial schedule and will continue until the end of the neoadjuvant phase.

  3. Step 3

    Infusion treatments

    You will receive a series of intravenous infusions on the days specified by the trial schedule. each infusion contains a specific medication with the dose shown below:

    docetaxel 80 mg/4 ml concentrate for solution for infusion: 75 mg/m2 administered as an iv infusion.

    farmorubicina 50 mg powder for solution for infusion: 90 mg/m2 administered as an iv infusion.

    keytruda 25 mg/ml concentrate for solution for infusion: 200 mg administered as an iv infusion.

    ogivri 420 mg powder for concentrate for solution for infusion: 8 mg/kg administered as an iv infusion.

    paclitaxel 6 mg/ml concentrate for solution for infusion: 80 mg/m2 administered as an iv infusion.

    perjeta 420 mg concentrate for solution for infusion: 840 mg administered as an iv infusion.

    carboplatin‑teva 10 mg/ml concentrate for solution for infusion: 225 mg administered as an injection.

    kadcyla 160 mg powder for concentrate for solution for infusion: 3.6 mg/kg administered as an iv infusion.

    endoxan baxter 1 g powder for solution for injection: 600 mg/m2 administered as an injection.

    The frequency of each infusion (for example, every three weeks) follows the protocol and will be explained to you before each visit.

  4. Step 4

    Regular monitoring visits

    Throughout the treatment period you will attend scheduled clinic visits where health professionals will check your vital signs, perform blood tests, and assess any side effects.

    You will also undergo repeat breast mri scans and, when required, additional image‑guided biopsies to evaluate the response of the tumor to the therapy.

    Questionnaires about quality of life (eortc qlq‑c30, qlq‑br45, decision regret scale) will be completed at designated times.

  5. Step 5

    End of treatment assessment

    When the neoadjuvant phase is completed, you will have a final imaging assessment and a surgical procedure to remove any remaining tissue.

    The pathology report will determine whether a pathological complete response (pcr) was achieved.

    Subsequent follow‑up visits will monitor disease‑free survival, distant disease‑free survival, and overall survival according to the study timeline.

Who can join the trial?

10 criteria

  • Be at least 18 years old.
  • Both women and men with breast cancer are allowed to participate.
  • Have an overall health score of 0 or 1 on the ECOG scale, which means you are fully active or able to do light work.
  • Have a breast cancer diagnosis confirmed by looking at tissue under a microscope (this is called histologically confirmed).
  • If your cancer is triple‑negative breast cancer (TNBC), it must have low levels of estrogen and progesterone receptors (ER/PgR less than 10%) and not have excess HER2 protein (HER2‑).
  • If your cancer is HER2‑positive (HER2+), it must meet the testing standards set by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP).
  • If your cancer is hormone‑receptor‑positive (HR+), it must have estrogen or progesterone receptors at 10% or higher (ER and/or PgR ≥ 10%) and not have excess HER2 (HER2‑).
  • Be in stage I, II, or IIIa of breast cancer according to the 8th edition of the AJCC staging system, and not have tumors classified as T4 or lymph node involvement classified as N3.
  • Agree to have breast imaging tests, including magnetic resonance imaging (MRI) and ultrasound (US), and to have a small tissue sample taken with a vacuum‑assisted biopsy (VAB biopsy).
  • Sign an informed consent form, which means you understand the study and agree to take part.

Who cannot join the trial?

6 criteria

  • Having cancer that has spread to many lymph nodes (N3) or a large tumor (T4), including a type called inflammatory breast cancer.
  • Having a health problem that makes chemotherapy (medicine that kills cancer cells) or radiotherapy (high‑energy radiation that destroys cancer cells) unsafe for you.
  • Having serious problems with major organs such as the heart, liver, or kidneys, known as organ dysfunction.
  • Being pregnant or breastfeeding.
  • Having a severe autoimmune disease, where your immune system mistakenly attacks your own body.
  • Having an active infection with HIV (human immunodeficiency virus), HBV (hepatitis B virus), or HCV (hepatitis C virus).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Kisqali

    is a pill that blocks proteins (CDK4/6) that help certain breast cancer cells grow. It is used together with hormone therapy for cancers that need estrogen to grow.

  • Tamoxifen

    is a tablet that blocks estrogen receptors on breast cancer cells, preventing estrogen from helping the tumor grow. It is used for cancers that are sensitive to hormones.

  • Capecitabine

    is an oral chemotherapy that the body changes into a drug that stops cancer cells from dividing. It is often given after surgery or for cancers that have spread.

  • Exemestane

    is a pill that reduces the amount of estrogen the body makes, which can slow the growth of hormone‑dependent breast cancers.

  • Letrozole

    works like exemestane by lowering estrogen levels, helping to treat breast cancers that need estrogen to grow.

  • Docetaxel

    is a chemotherapy drug given through an IV. It interferes with the way cancer cells divide, helping to shrink tumors.

What is already known about the treatment

  • Ribociclib

    This oral tablet is taken by mouth and works as a CDK4/6 inhibitor, slowing down cancer cell growth. It is an approved medicine widely used for hormone‑positive, HER2‑negative breast cancer and is well described in clinical studies. It blocks enzymes called cyclin‑dependent kinases that control cell division. Pharmacologically it belongs to the class of cyclin‑dependent kinase inhibitors.

  • Tamoxifen citrate

    This film‑coated tablet is swallowed and acts as a selective estrogen receptor modulator, blocking estrogen signals in breast tissue. Tamoxifen is an established, approved therapy for many types of breast cancer and has a long history in medical literature. It attaches to estrogen receptors and prevents estrogen from stimulating cancer cells. It is classified as a SERM (selective estrogen receptor modulator).

  • Capecitabine

    Taken as an oral tablet, capecitabine is a pro‑drug that is converted in the body to 5‑fluorouracil, a chemotherapy that stops DNA building in cancer cells. It is an approved treatment for metastatic and early‑stage breast cancer and is well documented in research. The drug interferes with the production of DNA and RNA, preventing tumor cells from multiplying. It belongs to the class of antimetabolite chemotherapies.

  • Exemestane

    This oral film‑coated tablet is an aromatase inhibitor that reduces the amount of estrogen made by the body. Exemestane is approved for post‑menopausal women with hormone‑sensitive breast cancer and is widely studied. It blocks the enzyme aromatase, lowering estrogen levels that can feed cancer growth. Pharmacologically it is an irreversible aromatase inhibitor.

  • Letrozole

    Administered as an oral tablet, letrozole is another aromatase inhibitor that lowers estrogen production. It is an approved and commonly used drug for hormone‑positive breast cancer in post‑menopausal women. By inhibiting aromatase, it cuts off the supply of estrogen that tumors need to grow. It is classified as a non‑steroidal aromatase inhibitor.

  • Docetaxel

    Given by intravenous infusion, docetaxel is a taxane chemotherapy that stabilizes microtubules and stops cancer cells from dividing. It is an approved drug for breast cancer and many other solid tumors, with extensive clinical data. The medication binds to tubulin, preventing the microtubule network from breaking down during cell division. It belongs to the taxane class of antimitotic agents.

Investigated diseases

  • Triple-negative breast cancer

    Triple-negative breast cancer is a type of breast cancer that lacks estrogen, progesterone, and HER2 receptors. It typically begins as a lump in the breast and can grow locally. Over time it may invade surrounding tissue and spread to nearby lymph nodes. If unchecked, cancer cells can travel through the bloodstream to distant sites such as the lungs, liver, or bones. The disease often shows rapid growth compared to other subtypes.

  • HER2‑positive breast cancer

    HER2‑positive breast cancer is a breast cancer that overexpresses the HER2 protein. It starts in the breast ducts or lobules and tends to grow more quickly than HER2‑negative cancers. Cancer cells can infiltrate surrounding tissue and spread to regional lymph nodes. Later, tumor cells may disseminate to distant organs. The HER2 signal drives cell division and tumor expansion.

  • Hormone receptor‑positive HER2‑negative breast cancer

    Hormone receptor‑positive HER2‑negative breast cancer expresses estrogen or progesterone receptors but lacks excess HER2 protein. It usually begins as a slow‑growing tumor in the breast. The tumor can extend into nearby tissue and involve sentinel lymph nodes. Over time, cancer cells may travel to distant sites, often bone. Hormone signaling supports its gradual progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527524-27-00Protocol codeODEONEstimated enrolment1 patient

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.