Ovarian Suppression Therapy for Breast Cancer
(OVELIA Trial)
Recruiting in Palo Alto (17 mi)
+71 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Tolmar Inc.
Must be taking: Endocrine therapy
Must not be taking: SERMs, mTOR inhibitors
Disqualifiers: BMI, Breastfeeding, Life expectancy, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests TOL2506, a treatment that stops ovaries from working, in premenopausal women and men with hormone-sensitive breast cancer. It aims to reduce hormone levels to slow down or stop cancer growth. TOL2506 is a treatment that stops ovaries from working, similar to other ovarian suppression methods.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but it does mention that you cannot use certain hormonal therapies, anticancer medications, or drugs that affect bone density or the QT/QTc interval. It's best to discuss your current medications with the trial team to see if any need to be stopped.
What data supports the effectiveness of the drug TOL2506 for breast cancer?
Research shows that leuprolide acetate, a component of TOL2506, was effective in treating metastatic breast cancer in premenopausal women, with 44% experiencing a partial response and 20% having stable disease. This suggests potential effectiveness for TOL2506 in similar conditions.
12345Is ovarian suppression therapy with leuprolide acetate generally safe for humans?
Leuprolide acetate, used in various formulations for different conditions, has been generally well tolerated in clinical studies. Common side effects include hot flashes and mild swelling, but no serious adverse effects were observed in studies involving prostate cancer patients.
12678How is the drug TOL2506 different from other treatments for breast cancer?
TOL2506, also known as leuprolide acetate, is unique because it is a gonadotropin-releasing hormone analogue that works by suppressing ovarian function, which can be beneficial in hormone-sensitive breast cancer. Unlike traditional chemotherapy, it is administered as a depot injection, which means it is given less frequently and can be more convenient for patients.
134910Eligibility Criteria
This trial is for premenopausal women aged 18-49 with HR+, HER2-negative breast cancer who are candidates for endocrine therapy and ovarian suppression. Men with the same cancer type may also participate. Participants must have normal liver, kidney function, and not be on certain medications or treatments that could interfere with the study.Inclusion Criteria
Your follicle stimulating hormone (FSH) level is less than 40 IU/L.
I have regular menstrual cycles or confirmed premenopausal status.
My breast cancer is early to mid-stage, hormone receptor positive, and HER2 negative.
+6 more
Exclusion Criteria
I haven't used tamoxifen, SERMs, aromatase inhibitors, mTOR inhibitors, or hormone therapy in the 3 months before my breast cancer diagnosis.
I have received hormone therapy for breast cancer since my diagnosis.
I haven't taken drugs or supplements for bone density in the last 6 months.
+37 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial and full screening visits
Treatment
Participants receive TOL2506 in combination with endocrine therapy for ovarian suppression
48 weeks
Regular visits for dosing and monitoring at Weeks 6, 12, 24, 36, and 48
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Safety Extension
Participants may be eligible to participate in a Safety Extension Study under a separate protocol
Participant Groups
The effectiveness of TOL2506 in suppressing ovarian function alongside standard therapies (tamoxifen or aromatase inhibitors) is being tested over a 48-week period. The study will assess if this treatment can maintain low estradiol levels in women and testosterone levels in men.
1Treatment groups
Experimental Treatment
Group I: Active Comparator: TOL2506Experimental Treatment5 Interventions
TOL2506 in combinatination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506 is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Eligard for:
- Advanced prostate cancer
- Central precocious puberty
- Endometriosis
- Anemia caused by uterine fibroids
🇪🇺 Approved in European Union as Eligard for:
- Prostate cancer
- Precocious puberty
- Endometriosis
- Uterine fibroids
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BRCR Medical Cancer Center Inc.Plantation, FL
Revive Research Institute, Inc.Farmington Hills, MI
Texas Oncology-DentonDenton, TX
Texas Oncology- Flower MoundFlower Mound, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Tolmar Inc.Lead Sponsor
References
Leuprolide acetate in the treatment of refractory or persistent epithelial ovarian cancer. [2017]Leuprolide acetate (Lupron, TAP Pharmaceuticals, North Chicago), a gonadotropin-releasing hormone analogue, was administered subcutaneously at a 1-mg dose for a minimum of 8 weeks to 23 patients with refractory epithelial ovarian cancer. Eighteen of these patients were evaluable. There were no complete responses. Four patients (17%) had a partial response, with a median duration of 52 weeks. Three of six patients with grade 1 carcinomas had a partial response and two had stabilized disease. There was only one response among 15 patients with grade 2 or 3 disease. Therapy was well tolerated, with three patients complaining of hot flashes and two of mild pedal edema. Leuprolide acetate thus shows evidence of antitumor activity against refractory grade 1 epithelial adenocarcinoma of the ovary. Further trials with larger numbers of patients should be conducted.
A 12-month clinical study of LA-2585 (45.0 mg): a new 6-month subcutaneous delivery system for leuprolide acetate for the treatment of prostate cancer. [2022]The safety, efficacy and pharmacokinetics of LA-2585, a new 6-month subcutaneous depot of leuprolide acetate (Atrix Laboratories, Fort Collins, Colorado) were investigated in patients with prostate cancer.
Treatment of advanced refractory ovarian carcinoma with a gonadotropin-releasing hormone analogue. [2019]Leuprolide acetate, a gonadotropin-releasing hormone analogue, produced a variety of beneficial therapeutic responses in five patients with ovarian carcinoma. Four patients had failed intensive chemotherapy with alkylating agents, cisplatin, and Adriamycin. All had one or more clinical conditions that precluded treatment with cytotoxic agents and characteristics associated with resistance to hormone therapy. Our findings support evaluation of expanded eligibility criteria for new hormonal therapy in cases of refractory ovarian carcinoma.
A phase II trial of leuprolide acetate in patients with advanced epithelial ovarian carcinoma. A Gynecologic Oncology Group study. [2019]Twenty-five evaluable patients with advanced or recurrent epithelial ovarian carcinoma that was no longer controllable with surgery, radiation therapy, and/or chemotherapy were treated with leuprolide acetate, a gonadotropin-releasing hormone agonist, 1 mg subcutaneously daily. One partial response (4%) was observed among the 25 patients. The upper 95% confidence bound of the response rate is 17.6%. Fifteen patients (60%) exhibited stable disease for at least 8 weeks, and 9 patients (36%) developed progressive cancer while receiving treatment. The regimen was well tolerated with no patient experiencing life-threatening toxicity. Mild toxicities included leukopenia in 2 patients (8%), thrombocytopenia in 2 patients (8%), gastrointestinal toxicity in 5 patients (20%), anemia in 4 patients (16%), hot flashes in 1 patient (4%), and facial swelling in 1 patient (4%). Thus, leuprolide acetate was well tolerated but has insignificant activity in treating patients with chemotherapy-refractory ovarian adenocarcinoma.
Medical castration produced by the GnRH analogue leuprolide to treat metastatic breast cancer. [2017]Leuprolide (Lupron, TAP Pharmaceuticals, North Chicago), a gonadotropin-releasing hormone analogue, was administered to 26 premenopausal women with metastatic breast cancer. Of 25 evaluable patients, 11 (44%) had a partial response with a median duration of 39 weeks and five (20%) remained stable. Six patients showed early rapid progression of their disease. Toxicity was mild and included hot flashes, nausea, vomiting, and headache. Leuprolide induced amenorrhea in all patients who received treatment for ten weeks or longer. We conclude that this GnRH analogue provides a safe and effective means of producing medical castration in premenopausal patients with metastatic breast carcinoma.
Six-month gonadotropin releasing hormone (GnRH) agonist depots provide efficacy, safety, convenience, and comfort. [2023]Two different 6-month GnRH agonist depot formulations approved for palliative treatment of advanced and metastatic prostate cancer in the United States - leuprolide acetate 45 mg and triptorelin pamoate 22.5 mg - provide patients with efficacy and safety comparable to those of existing 1-, 3-, and 4-month GnRH agonist depots. However, the 6-month formulations can increase patient convenience, comfort, and compliance by reducing the number of physician visits and injections required. At the conclusion of their pivotal trials, the 6-month formulations demonstrated efficacy rates in achieving chemical castration (serum testosterone ≤50 ng/dL) that ranged between 93% and 99%. As with existing GnRH agonist depot formulations, hot flashes represented the most common adverse event reported in trials of 6-month leuprolide acetate or triptorelin. As such, these products may prove useful not only for their labeled indication, but also as adjuncts to other treatments such as radical prostatectomy, radiotherapy, and chemotherapy. We recommend further research, including head-to-head trials between the 6-month GnRH depots, to refine our understanding of these products.
A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. [2023]The safety, efficacy and pharmacokinetics of a unique 3-month subcutaneous depot of leuprolide acetate were investigated in patients with prostate cancer.
Comparative in vitro release and clinical pharmacokinetics of leuprolide from Luphere 3M Depot, a 3-month release formulation of leuprolide acetate. [2017]A 3-month depot formulation of leuprolide acetate (Luphere 3M Depot) with a mean microsphere diameter of 22.3 μm was prepared aseptically by spray-drying glacial acetic acid solution of the drug and polylactic acid, and lyophilization in a d-mannitol solution. The encapsulation efficiency and loading content of the drug in the Luphere 3M Depot were 94.7% and 9.92% (w/w), respectively. The in vitro release of leuprolide from the depot was substantially delayed and the release profile was similar to that of Lucrin Depot (Abbott Korea, Korea). The safety and pharmacokinetics of leuprolide were investigated over a period of 42 days in 20 prostate cancer patients following a subcutaneous injection of Luphere 3M or Lucrin Depot suspensions (leuprolide acetate dose of 11.25 mg) in a multi-center, randomized, single dose, parallel study. Both formulations were well tolerated by the patients and no serious adverse effects were observed during and after the study. No significant differences were observed in the maximum serum concentration (Cmax) and area under the curve (AUClast) of leuprolide between the two formulations. The results suggest comparable safety and efficacy profiles of Luphere 3M Depot and Lucrin Depot in clinical situations.
Leuprolide acetate as a salvage-therapy in relapsed epithelial ovarian cancer. [2020]A large number of studies have been conducted in patients affected by epithelial ovarian cancer to assess the potential utility of a variety of different regimens in patients who have relapsed after primary surgery and adjuvant chemotherapy. In this open prospective study, 32 patients with ovarian cancer of epithelial histology who had relapsed after platinum-based line chemotherapy and had exhausted all standard treatments, received Leuprolide acetate depot 3.75 mg, intramuscularly once a month until tumor progression. Four patients (12.5%) had clinical and/or radiological partial response; remission was then maintained for a mean duration of 8.7 months (range 6-11 months) before new progression occurred. Five patients (15.6%) remained stable for a mean time of 5.2 months (range 4-6 months) and 23 patients (71.9%) continued to progress following therapy and have since died by tumor with a median survival of 3.6 months after initiation of the protocol. Treatment is well-tolerated and no toxicity has been noted. These data stress the significant activity of Leuprolide acetate as a salvage therapy in patients with relapsed advanced epithelial ovarian cancer after previous platinum-based chemotherapies.
Comparison of FSH flare with and without pretreatment with oral contraceptive pills in poor responders undergoing in vitro fertilization. [2013]To compare FSH, LH, estrogen, and P flare response following 1 mg lupron injection in poor responders with or without pretreatment with oral contraceptive pills (OCPs).