Combination of estradiol and olaparib for advanced breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and optimal dosage of olaparib when combined with 17b-estradiol in post-menopausal women suffering from advanced ER+/HER2- breast cancer. Participants will receive the combination treatment for two cycles, followed by single-agent estradiol until disease progression occurs. The study will assess clinical benefits, progression-free survival, objective response rates, tumor metabolic response, and any associated toxicities. This approach targets patients with endocrine-resistant breast cancer who have previously undergone endocrine therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Post-menopausal women with ER+/HER2- breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative intent.
* Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting.

Exclusion Criteria:

* During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:

  o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted.
* Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.
* Any radiation therapy in the last 2 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* Concomitant use of known strong or moderate CYP3A inhibitors.
* Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.
* History of any of the following:

  * Deep venous thrombosis
  * Pulmonary embolism
  * Stroke
  * Acute myocardial infarction
  * Congestive heart failure
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%
  * Severe renal impairment (creatinine clearance ≤ 30 mL/min).

Where it's running

• Dartmouth Cancer Center
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Principal investigator: Mary Chamberlin, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Research Nurse
• Email: Cancer.Research.Nurse@dartmouth.edu
• Phone: 1-800-639-6918

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.