MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01)
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| ClinicalTrials.gov Identifier: NCT03767335 |
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Recruitment Status :
Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : May 24, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced or Metastatic Breast Cancer | Drug: MEN1611 Drug: Trastuzumab Drug: Fulvestrant | Phase 1 |
This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease.
MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide 3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611 given in combination with Trastuzumab with/without Fulvestrant.
The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review Committee.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Step 1 Dose escalation / Step 2 Cohort expansion in two selected breast cancer sub-populations |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy |
| Actual Study Start Date : | July 19, 2018 |
| Estimated Primary Completion Date : | December 21, 2023 |
| Estimated Study Completion Date : | December 21, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MEN1611
MEN1611 + Trastuzumab +/- Fulvestrant
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Drug: MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle Drug: Trastuzumab Trastuzumab solution for infusion administered weekly via IV Drug: Fulvestrant Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women) |
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) [ Time Frame: 28 Days ]
- Treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Histologically confirmed invasive adenocarcinoma of the breast
- Known HER2+ breast cancer
- Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample
- > 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab
- Radiological documented evidence of progressive disease
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Main Exclusion Criteria:
- Previous treatment with PI3K inhibitors
- Brain metastases untreated, unless treated > 4 weeks and only if clinically stable and not receiving corticosteroids
- History of clinically significant bowel disease
- ≥ grade 2 diarrhoea
- History of significant, uncontrolled, or active cardiovascular disease
- Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety
- Not controlled diabetes mellitus (glycated haemoglobin [HbA1c] >7%) and fasting plasma glucose >126 mg/dL
- Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767335
Show 27 study locations
| Study Chair: | Martine Piccart, MD PhD | Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium |
| Responsible Party: | Menarini Group |
| ClinicalTrials.gov Identifier: | NCT03767335 |
| Other Study ID Numbers: |
MEN1611-01 2017-004631-36 ( EudraCT Number ) |
| First Posted: | December 6, 2018 Key Record Dates |
| Last Update Posted: | May 24, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Advanced Breast Cancer Metastatic Breast Cancer PI3K inhibitor HER2-positive |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab Fulvestrant Antineoplastic Agents, Immunological |
Antineoplastic Agents Antineoplastic Agents, Hormonal Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |