7 Participants Needed

Copanlisib + Fulvestrant for Hormone Receptor-Positive Cancers

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Overseen ByTimothy Yap, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive (HR+) solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase (PI3K) pathway.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot use certain strong enzyme inducers or inhibitors from 14 days before starting the study. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug combination Copanlisib + Fulvestrant for hormone receptor-positive cancers?

Research shows that Fulvestrant is effective in treating advanced hormone receptor-positive breast cancer, especially in patients who are sensitive to endocrine therapy. It has been compared favorably to other treatments like anastrozole, suggesting its potential benefit in combination therapies.12345

Is the combination of Copanlisib and Fulvestrant safe for humans?

Copanlisib has been studied in various cancers and generally shows a manageable safety profile, with common side effects including high blood pressure, diarrhea, and high blood sugar. Fulvestrant, also known as Faslodex, is commonly used in hormone receptor-positive breast cancer and is generally well-tolerated, though it can cause side effects like nausea and injection site pain.678910

How is the drug combination of Copanlisib and Fulvestrant unique for hormone receptor-positive cancers?

The combination of Copanlisib and Fulvestrant is unique because it pairs Fulvestrant, a pure estrogen receptor antagonist that blocks and degrades estrogen receptors, with Copanlisib, a drug that inhibits specific enzymes involved in cancer cell growth. This combination targets both hormone-driven and growth factor-driven pathways, potentially offering a more comprehensive approach to treating hormone receptor-positive cancers compared to treatments that target only one pathway.511121314

Research Team

Timothy Yap | MD Anderson Cancer Center

Timothy Yap

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced hormone receptor-positive solid tumors, including ovarian, endometrial, or breast cancer. Participants must have specific genetic alterations in the PI3K pathway and no available standard therapy that prolongs survival. They should be healthy enough to follow the study protocol and not pregnant or breastfeeding. Men must use barrier contraception.

Inclusion Criteria

My cancer is ER+ or PR+ and has spread beyond its original site.
I am able to get out of my bed or chair and move around.
There are no standard treatments left that can extend my life.
See 7 more

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.
It's been over 4 weeks or 5 half-lives since my last chemotherapy or experimental treatment.
I am currently being treated for active hepatitis B or C.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Confirmation

Evaluate the safety, tolerability, and dose-limiting toxicities of copanlisib in combination with fulvestrant to confirm the recommended phase 2 doses

4 weeks
3 visits (in-person) for copanlisib administration, 2 visits (in-person) for fulvestrant administration

Dose Expansion

Assess the efficacy of copanlisib in combination with fulvestrant in 3 indication-specific cohorts

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Copanlisib
  • Fulvestrant
Trial OverviewThe trial tests the effectiveness and safety of combining copanlisib (a PI3K inhibitor) with fulvestrant in treating cancers that are positive for estrogen/progesterone receptors and have certain genetic changes activating the PI3K pathway.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose expansion:Experimental Treatment2 Interventions
The dose expansion part will enroll in 3 indication-specific cohorts with 13 to 26 patients
Group II: Part 1: Dose confirmationExperimental Treatment2 Interventions
Up to 6 evaluable patients to confirm a single combination dose of copanlisib and fulvestrant

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Bayer

Industry Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

In a phase II study involving 205 postmenopausal women with advanced hormone receptor-positive breast cancer, high-dose fulvestrant (500 mg/month) showed a clinical benefit rate (CBR) similar to anastrozole (72.5% vs. 67.0%), indicating comparable effectiveness as first-line therapy.
Fulvestrant high-dose was associated with a significantly longer time to progression (TTP) compared to anastrozole, suggesting it may provide a more durable response in treatment, while both therapies had similar safety profiles.
Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study.Robertson, JF., Llombart-Cussac, A., Rolski, J., et al.[2022]
In a study of 400 postmenopausal women with advanced breast cancer, fulvestrant was found to be as effective as anastrozole in delaying disease progression, with a median time to progression of 5.4 months for fulvestrant compared to 3.4 months for anastrozole.
Fulvestrant also demonstrated a significantly longer duration of response in patients who responded to treatment, with a median duration of 19.0 months compared to 10.8 months for anastrozole, indicating it may provide a more sustained benefit.
Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial.Osborne, CK., Pippen, J., Jones, SE., et al.[2022]
In a study of 521 premenopausal and postmenopausal patients with endocrine-resistant metastatic breast cancer, those treated with palbociclib and fulvestrant showed a higher rate of prolonged benefit (29%) compared to those on placebo and fulvestrant (15%).
Long-term responders to palbociclib-fulvestrant tended to have less disease burden at baseline and lower rates of certain mutations, but no specific molecular or clinical factors were identified as predictors of long-term benefit.
Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3.Cristofanilli, M., DeMichele, A., Giorgetti, C., et al.[2022]

References

Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. [2022]
Anthropometric, clinical and molecular determinants of treatment outcomes in postmenopausal, hormone receptor positive metastatic breast cancer patients treated with fulvestrant: Results from a real word setting. [2022]
Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. [2022]
Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3. [2022]
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. [2022]
First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous pan-class I phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors and non-Hodgkin's lymphomas. [2022]
Phase I dose-escalation study of copanlisib in combination with gemcitabine or cisplatin plus gemcitabine in patients with advanced cancer. [2022]
A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors. [2019]
Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A Budget Impact Analysis of the Introduction of Copanlisib for Treatment of Relapsed Follicular Lymphoma in the United States. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. [2022]
Fulvestrant ("Faslodex"): clinical experience from the Compassionate Use Programme. [2018]
Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study. [2018]
Fulvestrant in the management of postmenopausal women with advanced, endocrine-responsive breast cancer. [2018]