Trial Outcomes & Findings for Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Stage II-III Breast Cancer (NCT NCT03132467)

NCT ID: NCT03132467

Last Updated: 2024-06-05

Results Overview

Feasibility established if all 15 patients enroll within 12 months of starting the study. The start date for measuring feasibility will be the date the first patient is screened.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2024-06-05

Participant Flow

This was a feasibility trial of combined checkpoint blockade in patients with HR+/HER2 neg primary breast cancer to determine whether the strategy of combined checkpoint blockade therapy prior to chemotherapy could be an effective frontline therapy. Patients were eligible if they had hormone receptor positive, HER2 negative breast cancer and had neoadjuvant chemotherapy planned.

16 participants enrolled, 8 participants were inevaluable.

Participant milestones

Measure	Treatment (Tremelimumab, Durvalumab) Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Treatment (Tremelimumab, Durvalumab) Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Stage II-III Breast Cancer

Baseline characteristics by cohort

Measure	Treatment (Tremelimumab, Durvalumab) n=8 Participants Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The trials primary endpoint of 15 participants enrollment feasibility within 2 years was NOT met due to early termination of the study.

Feasibility established if all 15 patients enroll within 12 months of starting the study. The start date for measuring feasibility will be the date the first patient is screened.

Outcome measures

Measure

Treatment (Tremelimumab, Durvalumab) n=8 Participants Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"

Feasibility of Enrolling 15 Patients Within 2 Years

8 Participants

PRIMARY outcome

Timeframe: 2 months

To evaluate the safety and tolerability of tremelimumab plus durvalumab in patients with HR+/HER2 neg breast cancer. Adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v4.03.

Outcome measures

Measure	Treatment (Tremelimumab, Durvalumab) n=8 Participants Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Safety and Tolerability of Tremelimumab Plus Durvalumab in Participants With HR+/HER2 Neg Breast Cancer. Serious Adverse Events	3 adverse events
Safety and Tolerability of Tremelimumab Plus Durvalumab in Participants With HR+/HER2 Neg Breast Cancer. Adverse Events	8 adverse events

Adverse Events

Treatment (Tremelimumab, Durvalumab)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Tremelimumab, Durvalumab) n=8 participants at risk Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Gastrointestinal disorders Colitis	12.5% 1/8 • Number of events 1 • 2 months
Endocrine disorders Adrenal insufficiency	12.5% 1/8 • Number of events 1 • 2 months
Endocrine disorders Hyperthyroidism	12.5% 1/8 • Number of events 1 • 2 months

Other adverse events

Measure	Treatment (Tremelimumab, Durvalumab) n=8 participants at risk Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
Eye disorders Conjunctivits	12.5% 1/8 • Number of events 1 • 2 months
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • 2 months
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1 • 2 months
Gastrointestinal disorders Dysgeusia	12.5% 1/8 • Number of events 1 • 2 months
Endocrine disorders Hot flashes	12.5% 1/8 • Number of events 1 • 2 months
Gastrointestinal disorders Mucositis	25.0% 2/8 • Number of events 2 • 2 months
Skin and subcutaneous tissue disorders Pruritis	12.5% 1/8 • Number of events 1 • 2 months
Skin and subcutaneous tissue disorders Rash	25.0% 2/8 • Number of events 2 • 2 months

Additional Information

Dr. Jennifer Litton, MD- VP, Clinical Research, Clinical Research

UT MD Anderson Cancer Center

Phone: (713) 792-2817

Email: jlitton@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place