Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of fulvestrant and palbociclib combination for postmenopausal women with hormone receptor-positive metastatic breast cancer who completed 5 years of hormone therapy or have new metastatic disease

Fast replyRegistered drug
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

This clinical trial focuses on treating metastatic breast cancer in postmenopausal women whose cancer is hormone receptor-positive and HER2-negative. These specific characteristics mean that the cancer cells are influenced by hormones but do not have high levels of a protein called HER2. The study examines the effectiveness of combining two medications: fulvestrant (Faslodex), which is given by injection under the skin, and palbociclib, which is taken as oral capsules.

The purpose of this research is to compare how well fulvestrant works when given alone with placebo versus when it is combined with palbociclib. The study specifically looks at how long patients remain free from disease progression during treatment. This research includes women who have previously received at least 5 years of hormone therapy and remained disease-free for more than 12 months after completing that treatment, or women who were diagnosed with metastatic disease from the beginning.

During the study, participants receive either fulvestrant with palbociclib or fulvestrant with placebo. Fulvestrant is administered as a 500 mg injection, while palbociclib is taken as a 125 mg daily capsule. The treatment continues for up to 480 days, during which doctors monitor the cancer's response to treatment and check for any side effects. Throughout the study, participants undergo regular medical examinations and imaging tests to evaluate how the disease responds to treatment.

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

    Initial medical assessment

    You will undergo tests to confirm your eligibility, including blood tests to check organ and bone marrow function

    Your tumor tissue sample will be tested centrally for hormone receptor status and HER2 status

    Your doctor will assess your overall health status and perform necessary medical examinations

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    Group 1: Fulvestrant (Faslodex) 500mg injection plus placebo

    Group 2: Fulvestrant (Faslodex) 500mg injection plus Palbociclib

  3. Step 3

    Treatment administration

    Fulvestrant will be given as an injection under the skin

    If assigned to the second group, you will also take Palbociclib by mouth

    Your doctor will provide specific instructions about when to take the medications

  4. Step 4

    Regular monitoring

    You will have regular medical check-ups to monitor your health

    Imaging tests will be performed to assess how your disease responds to treatment

    Blood tests will be conducted to monitor your organ function and blood counts

    You will complete quality of life questionnaires during the study

  5. Step 5

    Treatment continuation

    Treatment will continue as long as you are benefiting from it and not experiencing unacceptable side effects

    Your doctor will regularly assess your disease status using imaging tests

    The study will track your progress for at least one year to measure how long the treatment prevents cancer progression

Who can join the trial?

14 criteria

  • Must sign an informed consent document before starting any study procedures
  • Age 18 or older
  • Expected survival of at least 12 weeks
  • Have adequate organ and bone marrow function, including: - Normal white blood cell counts - Normal platelet levels - Adequate hemoglobin levels - Normal kidney function - Normal liver function tests
  • Willing to provide biological samples for research testing
  • Able to attend scheduled visits and follow the treatment plan
  • Must have available tumor tissue sample for testing
  • Confirmed breast cancer that has spread (metastatic disease) that cannot be treated with surgery or radiation alone
  • Tumor must be hormone receptor-positive (responds to hormones) based on latest testing
  • Tumor must be HER2-negative (does not have high levels of HER2 protein) based on latest testing
  • Must have received at least 5 years of hormone therapy for early breast cancer and remained cancer-free for more than 12 months after completing treatment, OR have newly diagnosed metastatic disease
  • Must have at least one tumor site that can be measured by scans or physical examination
  • Must be postmenopausal, meaning either: - Had surgery to remove both ovaries - Age over 60 - Age 60 or younger with no menstrual periods for 12+ months
  • Must have good physical function ability (ECOG Performance Status of 0-2, meaning able to care for self and up at least 50% of waking hours)

Who cannot join the trial?

9 criteria

  • Male patients are not eligible for this study
  • Patients under 18 years of age cannot participate
  • Women who are not postmenopausal (still having menstrual periods) are excluded
  • Patients who have not previously received at least 3-5 years of endocrine therapy (hormone treatment) for breast cancer
  • Patients whose disease has returned within 12 months after completing endocrine therapy
  • Patients with breast cancer that is hormone receptor negative (does not respond to hormone therapy) or HER2-positive (has high levels of a protein called HER2)
  • Patients who stopped endocrine therapy less than 3 years ago
  • Patients who have not remained disease-free for at least 3 years after stopping endocrine therapy early (if stopped between 3-5 years of treatment)
  • Patients from vulnerable populations (such as those unable to provide informed consent)
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 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

  • Fulvestrant (Faslodex)

    is a hormone therapy medication used to treat hormone receptor-positive breast cancer in postmenopausal women. It works by blocking the effects of estrogen, which can help slow or stop the growth of certain breast cancer cells.

  • Palbociclib

    is a targeted therapy medication that works by blocking specific proteins (CDK4/6) that promote cancer cell growth. When combined with hormone therapy, it can help control the spread of hormone receptor-positive breast cancer more effectively than hormone therapy alone.

What is already known about the treatment

  • Fulvestrant (Faslodex)

    An injectable hormone therapy medication administered through intramuscular injection, used primarily in the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women. This medication works by blocking and degrading estrogen receptors, effectively preventing estrogen from stimulating cancer cell growth. It belongs to the class of drugs known as selective estrogen receptor degraders (SERDs) and is typically used when other hormone treatments have stopped working or in combination with other targeted therapies.

  • Palbociclib

    An oral targeted therapy medication taken in pill form, specifically designed to treat hormone receptor-positive, HER2-negative metastatic breast cancer in combination with hormone therapy. This medication works by blocking specific proteins called CDK4/6 that help control cell division, thereby slowing or stopping the growth of cancer cells. It belongs to the class of drugs known as cyclin-dependent kinase inhibitors and represents a significant advancement in targeted breast cancer treatment.

Investigated diseases

Metastatic Breast Cancer - A form of breast cancer where cancer cells have spread beyond the breast and nearby lymph nodes to other parts of the body. The cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs such as bones, liver, lungs, or brain. It develops when breast cancer cells gain the ability to break away from the original tumor and grow in new locations. The disease typically begins as a tumor in the breast tissue before spreading to distant areas. This stage of breast cancer is considered advanced and represents cancer progression beyond its initial site.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516132-10-00Protocol codeGEICAM/2014-12Estimated enrolment189 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

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.