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Study on Chemotherapy and Hormone Therapy for Women Over 70 with ER-Positive, HER2-Negative Breast Cancer Using Cyclophosphamide and Drug Combination

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for estrogen receptor (ER)-positive HER2-negative breast cancer in women over the age of 70. The study is exploring the effects of combining chemotherapy with hormone therapy compared to hormone therapy alone. The chemotherapy drugs being used in this study include cyclophosphamide, doxorubicin, and docetaxel. These medications are administered through an intravenous (IV) route, which means they are given directly into a vein.

The purpose of the study is to evaluate the benefit of adding chemotherapy to the treatment plan for elderly patients who have a high risk of cancer returning, as determined by a specific test called the Genomic Grade (GG). Participants in the study will receive treatment over a period of up to 12 months. The study will follow participants for four years to assess their overall survival, which means the length of time they live after starting the treatment. Other aspects being evaluated include the quality of life and any side effects experienced during the treatment.

This trial is part of a larger effort by the French UNICANCER Geriatric Oncology Group and Breast Group to improve treatment options for older women with this type of breast cancer. The study aims to provide valuable information on how effective the combination of chemotherapy and hormone therapy is in improving survival rates and quality of life for these patients. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

A written informed consent form is signed, agreeing to the use of medical data and participation in the study.

2 initial assessment

An initial assessment is conducted to evaluate overall health, including blood tests and imaging if necessary.

This assessment ensures that all health parameters meet the study requirements.

3 treatment phase

The treatment involves the administration of chemotherapy drugs: cyclophosphamide, doxorubicin, and docetaxel. These are given through an intravenous infusion.

The dosage and frequency of these medications are determined by the study protocol and are administered under medical supervision.

4 endocrine treatment

In addition to chemotherapy, endocrine treatment is provided to target hormone receptors in the cancer cells.

This treatment is tailored based on individual health needs and the specific characteristics of the cancer.

5 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor health status and response to treatment.

These appointments include physical exams, blood tests, and possibly imaging studies to assess the effectiveness of the treatment.

6 quality of life assessment

Quality of life is evaluated using specific questionnaires designed for elderly patients with cancer.

This assessment helps to understand the impact of treatment on daily life and overall well-being.

7 completion of study

The study concludes after a follow-up period of four years, during which overall survival and other health outcomes are evaluated.

Final assessments are conducted to gather data on the long-term effects of the treatment.

Who Can Join the Study?

  • Women aged 70 years or older.
  • Kidney function must be adequate, with a creatinine clearance of at least 40 mL/min. This is a measure of how well the kidneys are working.
  • Performance status (PS) should be 2 or less. This is a scale that measures how well a patient can perform ordinary tasks.
  • The patient must be able to follow the study protocol.
  • The patient must have signed a written informed consent form before any study-specific procedures. This includes agreeing to use stored tumor material for genetic testing and data collection.
  • The patient must have health insurance.
  • The patient must have a confirmed diagnosis of invasive breast cancer, regardless of the type.
  • Complete surgery must have been performed before joining the study. This could be a radical modified mastectomy or breast-conserving surgery, with either a sentinel lymph node procedure or axillary lymph node dissection.
  • Any lymph node status is acceptable, whether cancer is present in the lymph nodes (pN+) or not (pN0).
  • No visible signs of cancer spread to other parts of the body (metastases).
  • The cancer must be oestrogen receptor (ER)-positive, meaning at least 10% of the tumor cells show this characteristic when tested.
  • The cancer must be HER2-negative, which means it has a low score on specific tests (IHC score 0 or 1+, or IHC score 2+ with further negative tests).
  • Normal blood function is required, with specific levels for white blood cells (ANC ≥ 1,500/mm³), platelets (≥ 100,000/mm³), and hemoglobin (> 9 g/dl).
  • Normal liver function is required, with specific limits for bilirubin (≤ 1.25 times the upper limit of normal), ASAT and ALAT (≤ 1.5 times the upper limit of normal), and alkaline phosphatases (≤ 3 times the upper limit of normal).

Who Cannot Join the Study?

  • Patients who do not have oestrogen-receptor (ER)-positive HER2-negative breast carcinoma. This means the cancer must be sensitive to hormones and not have a specific protein called HER2.
  • Patients who are not considered elderly. The study is focused on older patients.
  • Patients who are male. The study is only for female patients.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Antoine Lacassagne Nice France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Centre Leon Berard Lyon France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Institut Regional Du Cancer De Montpellier Montpellier France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Clinique Victor Hugo Le Mans France
Capio La Croix Du Sud Quint-Fonsegrives France
Centre Oscar Lambret Lille France
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Et Universitaire De Limoges Limoges France
Centre Hospitalier Le Mans Le Mans France
Hopital Antoine Beclere Clamart France
Hopital NOVO Pontoise France
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Grand Hopital De Charleroi Charleroi Belgium
Institut de Cancérologie de l’Ouest Saint-Herblain France
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Institut Curie Paris France

Other Sites

Site Name City Country Status
Clinique Pasteur Toulouse France
Centre Paul Strauss STRASBOURG, Alsace France
CLINIQUE MUTUALISTE DE L’ESTUAIRE St Nazaire France
Institut Sainte Catherine Avignon France
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Hvlhwro Aweyqmmd Bobigny France
Cefdehih Mitegldi Rouen France
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Cvozqb dhmypfncdbxbwhidp Suejkwkljb Vannes France
Cxnaia Hphaosktlef Usgxcixfdhmln Hyxiil &wzymwh Hyxqvvb dq Mznt Mons Belgium
Hwxbzcni dt Lxptc Thonon-les-bains France
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Cyd Ssvbxnwtojuw Liege Belgium
Hcccijv do Lq Lvomzqhu &wqiguh Sjlq Jlxtazbi Haine-Saint-Paul Belgium
Cyzjeg Hivhubuiuam Ldnls &xpvtgs Mmebewescmlfrt Mont-de-Marsan France
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Cjgihd Hbyjgyslidv Isljwkwkrihdl du Mdsefy &dcedvd Lsw Mzxsdwc Meulan France
Cub dphmwtyqxfacra Epagny Metz Tessy France
Ctftui Hrqkwsurhqu Acnjo Lcbxs 74130 France
Uai Mptfjaoirvim Yvoir Belgium
Ctqeep Htdqqubkcft De Clhrbi Cholet France
Cpsaxk Hsgqclhfvru Bvvwdkti Asyzrkxmqu Vannes France
cflftm Hzxnbhnrwam df Wdbzgzow Pivmcty Tournai Belgium
Htoafen Dn Lnshrswig Libramont-Chevigny Belgium
Cvw Vtouybrt Verviers Belgium
Ctpmmq Hsbpuyfbqdh Psabr Smeaumxuciukpi Saint-Gregoire France
Iqenixgs Gxonion Reims France
Gdljhsmesp Dm Chkwpbixrat Syrydzlmz Rdoznk Rrsooxdff &tgwy Iupepbbzcz Svirl Srjvqlrjm Sarcelles France
Crxsjtfpd dj Sntbkgxvjukvad Arlon Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
12.04.2012
France France
Not recruiting
12.04.2012

Trial locations

Investigated Drugs:

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is being evaluated to see if it can improve overall survival in elderly patients with a high risk of breast cancer relapse. The specific drugs used in chemotherapy can vary, but they generally work by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Endocrine Treatment is a therapy used to treat breast cancer by blocking or lowering the amount of hormones in the body. This is particularly effective for oestrogen-receptor (ER)-positive breast cancer, as these cancer cells need oestrogen to grow. Endocrine treatment can involve medications that block the hormone receptors on cancer cells or reduce the production of hormones in the body.

Investigated Diseases:

Estrogen Receptor-Positive HER2-Negative Breast Carcinoma – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells, which means the cancer cells may receive signals from estrogen that could promote their growth. It is also HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surfaces. This subtype of breast cancer tends to grow more slowly than other types and may respond well to hormone therapy. The progression of the disease can vary, with some cases remaining localized while others may spread to nearby tissues or distant parts of the body. The risk of recurrence and progression is often assessed using genomic grading and other factors.

Trial ID:
2024-516996-34-00
Protocol code:
UC-0103/1102
NCT ID:
NCT01564056
Trial Phase:
Therapeutic confirmatory (Phase III)

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