Breast Cancer – TerSera TER-ZLDX-0101
Participating in a clinical trial with Profound means making a real difference in the lives of others facing similar health challenges.
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
Inclusion Criteria:
- Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.
- GnRH treatment-exposed <6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within <6 months of signing the informed consent.
- Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator’s assessment.
- Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
- Contraceptive use: Female participants may be enrolled if they are:
- Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR
- Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.
- Other criteria may apply
Complete the form and our team will reach out soon to help determine your eligibility.
