Giredestrant + Hormone Therapy for Early-Stage Breast Cancer
Recruiting in Palo Alto (17 mi)
+868 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Hoffmann-La Roche
Must not be taking: CDK4/6 inhibitors, CYP3A4 inhibitors
Disqualifiers: Stage IV breast cancer, Cardiac disease, Liver disease, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing giredestrant, a medication given after initial treatment to prevent breast cancer from returning. It focuses on patients with a specific type of early-stage breast cancer that is hormone-driven and at higher risk of recurrence. Giredestrant works by blocking the hormone estrogen from helping cancer cells grow. Giredestrant has shown promise in previous studies.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 21 days after the last dose of adjuvant chemotherapy before starting the study. Additionally, you cannot take strong CYP3A4 inhibitors or inducers within 14 days before starting the study treatment. If you are on these medications, you may need to stop them before participating.
What data supports the effectiveness of the drug Giredestrant combined with hormone therapy for early-stage breast cancer?
Endocrine therapy, which includes hormone treatments like tamoxifen and aromatase inhibitors, has been shown to reduce the risk of recurrence and death in women with hormone receptor-positive breast cancer. These therapies are well-established in both early-stage and advanced breast cancer, suggesting potential benefits when combined with new agents like Giredestrant.
12345Is Giredestrant + Hormone Therapy safe for humans?
Endocrine therapies, including tamoxifen and aromatase inhibitors, are generally considered safe for treating breast cancer, but they can have side effects that affect quality of life, such as cognitive issues and other adverse effects. It's important to discuss these potential side effects with your healthcare provider to ensure they are managed effectively.
56789What makes the drug Giredestrant unique for early-stage breast cancer?
Giredestrant is unique because it is a selective estrogen receptor degrader (SERD), which means it works by breaking down estrogen receptors in cancer cells, potentially offering a different mechanism compared to traditional hormone therapies that only block estrogen production or action.
310111213Eligibility Criteria
This trial is for adults with early-stage, estrogen receptor-positive, HER2-negative breast cancer who've had surgery and possibly chemotherapy (with a 21-day gap before joining the study). They should be within 12 months post-surgery, have no prior endocrine therapy or other cancers in the last 3 years, and must not be pregnant. Good organ function and performance status are required.Inclusion Criteria
My breast cancer is estrogen receptor positive and HER2 negative.
I finished my additional chemotherapy at least 3 weeks ago.
All my breast cancer tumors are ER positive and HER2 negative.
+25 more
Exclusion Criteria
Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
I am taking or will take a CDK4/6 inhibitor for early-stage cancer treatment.
I have severe liver disease, such as hepatitis or cirrhosis.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive adjuvant giredestrant or endocrine therapy of physician's choice
5 years
Substudy Treatment
Participants in the substudy receive giredestrant in combination with abemaciclib for up to 2 years, followed by giredestrant monotherapy for an additional 3 years
5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares Giredestrant, a new drug for breast cancer treatment after surgery (adjuvant), to standard endocrine therapies chosen by physicians. It's an open-label Phase III trial where participants are randomly assigned to either treatment group.
3Treatment groups
Experimental Treatment
Active Control
Group I: Substudy: Giredestrant + Abemaciclib, Then GiredestrantExperimental Treatment2 Interventions
In this substudy, participants will receive giredestrant in combination with abemaciclib for up to 2 years. Participants will continue with giredestrant monotherapy for an additional 3 years in order to complete a total of 5 years on study treatment.
Group II: Arm A: GiredestrantExperimental Treatment2 Interventions
Group III: Arm B: Endocrine Therapy of Physician's ChoiceActive Control2 Interventions
Endocrine Therapy of Physician's Choice is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Endocrine Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
🇺🇸 Approved in United States as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
🇨🇦 Approved in Canada as Endocrine Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
🇯🇵 Approved in Japan as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
🇨🇳 Approved in China as Endocrine Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
🇨🇭 Approved in Switzerland as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwest Cancer Specialists, P.C.Tigard, OR
Kaiser Permanente-Northwest RegionPortland, OR
Stefanie Spielman Comprehensive Breast CenterColumbus, OH
Virginia Commonwealth University - Massey Cancer CenterRichmond, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Hoffmann-La RocheLead Sponsor
References
Adjuvant hormonal therapy for premenopausal women with breast cancer. [2015]Endocrine therapy is a required element of the management of premenopausal women with early-stage steroid hormone receptor-positive breast cancer. There is uncertainty about how best to implement that therapy using the strategies of tamoxifen and estrogen deprivation as well as how to integrate these approaches with chemotherapy. Other research focuses on identification of improved markers for endocrine response or resistance and on the special side effects of endocrine therapy in young women.
Endocrine therapy for breast cancer: an overview. [2022]Endocrine therapy for breast cancer has been established in the adjuvant treatment for primary disease and in the treatment of advanced disease. The ER remains the best predictor of response although other factors exist and need to be identified. Pharmacological manipulation has been replacing ablative procedures. Tamoxifen used to be the most popular agent of choice and promising new agents include the pure anti-oestrogens and the third generation selective aromatase inhibitors. Ongoing and future studies will optimise treatment in established areas and will exploit its potential roles in preoperative use and chemoprevention.
Estrogen Down-regulator Fulvestrant Potentiates Antitumor Activity of Fluoropyrimidine in Estrogen-responsive MCF-7 Human Breast Cancer Cells. [2020]Endocrine therapy is clinically administered in hormone-responsive breast cancer. Combinations of fluoropyrimidine S-1 and an aromatase inhibitor or anti-estrogen are considered beneficial in Japan. Herein we assessed new combinations of S-1 and fulvestrant.
[Results and limits of endocrine therapy of carcinoma of the breast]. [2006]This review of endocrine therapy in breast carcinoma has been prepared principally with the aim of listing many persisting controversies in this area, even if significant advances have been made after the hormone receptor determination became available. Endocrine treatments include those indicated in an adjuvant setting and in metastatic disease. Indications for adjuvant endocrine therapy are still uncertain, even if a better selection of patients and the use of a non-toxic drug such as tamoxifen made more rationale and safer this type of treatment. Uncertainty is related to some doubts concerning consistency of survival advantages and to the relationship between advantages possibly obtainable by endocrine therapy or by adjuvant cytotoxic chemotherapy. Endocrine therapy can be cautiously combined with chemotherapy in amy adjuvant setting, as detrimental effects have been reported in some subsets of patients. Indications for endocrine treatment are mostly related to advanced disease, where more favourable results can presently be obtained through a better selection of patients and by less toxic hormone manipulations which are now available. In advanced disease, a sequential use of endocrine therapy and chemotherapy, or vice versa, is preferable to a concurrent administration of both types of treatment. Only some particular clinical situations suggest the latter type of approach. Some uncertainties are still present about the criteria by which, in the sequence, priority should be given to either therapeutic modality.
[Adjuvant treatment of breast cancer. Endocrine therapy]. [2013]For women with steroid receptor-positive breast cancers, endocrine therapy has proven to be a major component of adjuvant therapy reducing the risk of recurrence and death. The selective estrogen-receptor modulator (SERM) tamoxifen has been well established as safe and effective in the adjuvant care of both pre- and postmenopausal women. For premenopausal women, ovarian suppression is an important option to be considered. Additionally, aromatase inhibitors have recently demonstrated further benefits in postmenopausal women. The ideal sequencing of treatment with tamoxifen and/or an aromatase inhibitor is the subject of several ongoing studies.
Adjuvant hormonal therapy for early-stage breast cancer. [2010]Adjuvant endocrine treatment is an essential component in therapy for hormone receptor-positive breast cancer. Among postmenopausal patients, options include tamoxifen, aromatase inhibitors, or a sequence of these agents. Tamoxifen and aromatase inhibitors have distinctive side-effect profiles. Among premenopausal women, tamoxifen remains the standard treatment. The role of ovarian suppression in addition to tamoxifen is under investigation. Questions about the duration of adjuvant endocrine therapy, the use of biomarkers for treatment selection and prognosis, and the management of side effects of adjuvant endocrine therapy remain key areas of investigation.
The Modern Landscape of Endocrine Therapy for Premenopausal Women with Breast Cancer. [2020]The optimal endocrine therapy for premenopausal women with early and advanced breast cancer still remains an important and controversial issue. For over 30 years, tamoxifen has been the gold standard in the adjuvant setting. New therapeutic options, such as the addition of ovarian function suppression to oral endocrine therapy (either tamoxifen or aromatase inhibitors), can improve outcomes over tamoxifen alone in well-selected patients. Treatment duration has also been revisited, and extended therapy is becoming a new standard of care, especially in high-risk patients. Endocrine therapy for advanced disease still represents a challenge and a research priority. New drugs and combinations able to overcome endocrine resistance are at the horizon, and their role in premenopausal women should be better elucidated. Side effects and quality of life (including family planning considerations) play an important role in treatment selection and in the patients' treatment adherence and should always be discussed before start of treatment. The paper will specifically focus on how to integrate all new treatment options in the current armamentarium of endocrine therapy of premenopausal women, with the aim of best fine-tuning treatment selections according to the individual risk/benefit evaluation.
Effects of Endocrine Therapy on Cognitive Function in Patients with Breast Cancer: A Comprehensive Review. [2022]Endocrine therapy forms the backbone of systemic therapy for the majority of persons with early and late-stage breast cancer. However, the side effects can negatively affect quality of life, and impact treatment adherence and overall oncological outcomes. Adverse effects on cognition are common, underreported and challenging to manage. We aim to describe the nature, incidence, risk factors and underlying mechanisms of endocrine therapy-induced cognitive dysfunction. We conducted a comprehensive literature review of the studies reporting on cognitive dysfunction associated with endocrine therapies for breast cancer. We also summarise prevention and treatment strategies, and ongoing research. Given that patients are taking endocrine therapies for longer durations than ever before, it is essential that these side effects are managed pro-actively within a multi-disciplinary team in order to promote adherence to endocrine therapy and improve patients' quality of life.
[Endocrine therapy in breast cancer: efficacy and adverse events]. [2013]Endocrine therapy remains a mainstay in the treatment of endocrine-sensitive breast cancer. In the adjuvant setting, 5 years of endocrine therapy significantly reduces recurrence rate and mortality. Tamoxifen is the molecule of choice for premenopausal women, whereas for postmenopausal women aromatase inhibitors are currently part of the standard treatment. Endocrine therapy can induce side effects, which can affect patient's quality of life and lead to premature treatment interruption. Identification and adequately addressing these side effects is fundamental to maintain good treatment compliance and therefore improve breast cancer specific outcome.
Examination of the use of Exemestane in patients with metastatic breast cancer. [2016]Endocrine therapy is the preferred systemic treatment for metastatic breast cancer to prolong disease control. Aromatase inhibitors (AIs) are becoming the first choice for postmenopausal patients with metastatic breast cancer. AIs are divided into non-steroidal and steroidal agents.
Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. [2022]Endocrine therapy removes the influence of oestrogen on breast cancer cells and so hormonal treatments such as tamoxifen, megestrol acetate and medroxyprogesterone acetate have been in use for many years for advanced breast cancer. Aromatase inhibitors (AIs) inhibit oestrogen synthesis in the peripheral tissues and have a similar tumour-regressing effect to other endocrine treatments. Aminoglutethimide was the first AI in clinical use and now the third generation AIs, anastrozole, exemestane and letrozole, are in current use. Randomised trial evidence on response rates and side effects of these drugs is still limited.
Role of fulvestrant in the treatment of postmenopausal metastatic breast cancer patients. [2018]Endocrine therapy is considered the cornerstone treatment for postmenopausal women with hormone-receptor positive metastatic breast cancer. Fulvestrant is a selective estrogen receptor down-regulator (SERD) with demonstrated activity and efficacy in the treatment of these patients.
Role of anti-aromatase agents in postmenopausal advanced breast cancer. [2019]Endocrine therapy is a well-recognized approach to the treatment of postmenopausal patients with advanced breast cancer, particularly those with estrogen receptor-positive tumors. The availability of anti-aromatase agents, both reversible (nonsteroidal) and irreversible (steroidal), provides clinicians with additional hormonal treatment options.