Noninterventional, Multicentre, Prospective, Cohort Study Assessing the Quality of Life and Hormonal Levels in Premenopausal Patients With Hormone Receptor-positive and HER2-negative Early Breast Cancer in Italy - ROSE Study

Plain English Summary

Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment is a Not Applicable clinical trial sponsored by Ipsen studying Early-stage Breast Cancer. This study tests how triptorelin, along with other cancer treatments, affects the quality of life and hormone levels in premenopausal women with early-stage breast cancer. It is for women aged 18 and older who have been diagnosed with HR-positive, HER2-negative early breast cancer and are receiving specific hormone treatments. Participation involves regular check-ups and assessments of quality of life and hormone levels over a period of time. Alternatives include standard endocrine treatments for early breast cancer as prescribed by a doctor, without participation in this specific observational study. The trial aims to enroll 450 participants.

Official Summary

The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in addition to triptorelin, an endocrine cancer treatment. The study will also get more information about: - the effectiveness and safety of triptorelin; - the relationship that could exist between the characteristics of the disease and the treatment chosen by the Investigator.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 or older who are premenopausal and have been diagnosed with HR-positive, HER2-negative early breast cancer. Patients must be receiving triptorelin along with endocrine therapy or chemotherapy. Individuals with current or metastatic breast cancer, a history of other cancers (with some exceptions), or those currently in other clinical trials cannot participate. Women who have had their ovaries removed or irradiated are also excluded. This trial is studying Early-stage Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much participants' overall quality of life improves or changes significantly after 18 months of treatment, indicating how the treatment regimen affects their daily wel The specific primary outcome measures are: Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score. (At 18 months.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to understand the impact of a common treatment combination on the daily lives and hormonal balance of premenopausal women with early breast cancer, addressing a gap This research targets Early-stage Breast Cancer, where improved treatment options are needed.

Investor Insight

This observational study, sponsored by Ipsen, focuses on a specific patient population and treatment regimen, suggesting a need to better understand real-world outcomes and patient experience for trip

Is This Trial Right for Me?

Ask your doctor about the specific hormone treatments you will receive and how triptorelin is expected to work with them. Understand that participation involves regular visits for assessments of your quality of life and hormone levels, in addition to your standard cancer care. Be prepared to share your experiences and feelings about your health and treatment throughout the study period. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 450 participants

Primary Outcomes

• Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score. (At 18 months.)

Secondary Outcomes

• Tumor characteristics. (At baseline.)
• Percentage of days covered of compliance (At 18 months)
• Description of breast cancer treatment. (At baseline.)
• Identification of potential demographic factors predictive of any treatment switch. (At 18 months.)
• Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment. (At 18 months.)

Full Eligibility Criteria

Inclusion Criteria :

* Premenopausal (as per local definition) female patients aged ≥18 years on the day the informed consent is signed;
* Patients have histologically proven, HR-positive and HER2 negative breast cancer according to local definition, determined by immunohistochemistry, and up to stage IIIA. Note: patients with synchronous bilateral breast cancer and patients with breast cancer (BRCA)1/2 gene mutations are eligible;
* Patients have been prescribed adjuvant endocrine treatment with TAM or an AI plus triptorelin (either the 1 month or 3 month formulation) by their treating physician or, in alternative, triptorelin given in combination or consequent to neoadjuvant/adjuvant chemotherapy. Note: the decision to prescribe triptorelin is made by the treating physician prior to and independently of the decision to enroll the patient in this study;
* Patients must be documented to be disease-free at enrolment, as determined by the treating physician according to institutional standards. Note: in case the patient has been prescribed neoadjuvant treatment, the patient will receive surgery and be enrolled but will only remain in the study if disease-free condition is confirmed after surgery. If this condition is not confirmed, then the patient will be discontinued from the study;
* Written informed consent for trial participation must be signed and dated by the patient and the Investigator prior to enrolment;
* Patients have been informed of and agree to data transfer and handling, in accordance with national data protection guidelines;
* Patients must be accessible for follow-up;
* Patients may have received previous treatment with triptorelin for another indication, but the last administration must have occurred at least 6 months before enrolment.

Exclusion Criteria :

* Patient is currently enrolled in any other clinical study or has participated in one within the 12 weeks prior to the Inclusion visit, or is scheduled to receive a new investigational drug while this study is ongoing;
* Patient is not eligible for triptorelin treatment as guided by the product's label in Italy due to safety concerns or has prior history of no responsiveness to triptorelin (in case of previous triptorelin treatment);
* Patient has premenopausal status that cannot be defined;
* Patient has had bilateral oophorectomy or ovarian irradiation;
* Patient has current loco-regional relapse and/or distant metastatic disease;
* Patient has a history of prior (ipsi- and/or contralateral) invasive breast cancer;
* Patient has a history of malignancy other than invasive breast cancer, with the following exceptions: (a) Patients diagnosed, treated and disease-free for at least 5 years and deemed by the Investigator to be at low risk for recurrence of that malignancy are eligible; (b) Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: in situ breast ductal carcinoma; in situ cervical cancer; in situ thyroid cancer; nonmetastatic, no melanomatous skin cancers;
* Patient has concurrent disease or condition that would make study participation inappropriate or any serious medical disorder that would interfere with the patient's safety;
* Patient has psychiatric, addictive, or any other disorder that would prevent compliance with protocol requirements

Trial Locations

• Policlinico S. Orsola - Malpighi, Bologna, Italy
• Ospedale Oncologico "A. Businco", Cagliari, Italy
• Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy
• ASST Lecco, Lecco, Italy
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
• IRCCS San Raffaele, Milan, Italy
• Istituto Europeo di Oncologia, Milan, Italy
• Istituto Nazionale Tumori, Milan, Italy
• Ospedale S. Gerardo, Monza, Italy
• AORN Cardarelli, Naples, Italy
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Early-Stage Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Premenopausal Breast Cancer
• Endocrine Therapy
• Adjuvant Therapy
• Oncology
• Gynecologic Oncology
• Hormone Therapy

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