Trial Outcomes & Findings for CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer (NCT NCT03032406)

NCT ID: NCT03032406

Last Updated: 2025-07-22

Results Overview

For the primary endpoint of feasibility, we employed ongoing Bayesian toxicity monitoring after every 3 participants completed cycle 6, assuming a Beta (1,2) prior, equivalent to one DLT observed in 3 treated participants. Early termination of a treatment arm for toxicity (non-feasibility) would occur if the posterior probability that the toxicity rate exceeds the target maximum of 30% was greater than 75%. Trial enrollment and conduct was significantly impacted by the COVID pandemic, including shortage of HCQ and inability of enrolled patients to travel. To address this, we amended the protocol to allow study Arms C and D to be combined for feasibility assessment, given that the investigational treatment was the same in the two arms, enabling enrollment to be halted when the sample size needed for feasibility assessment was complete for all study treatments. Toxicity was assessed using CTCAE v4.0.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2025-07-22

Participant Flow

The target accrual was originally 60; but due to slow enrollment caused by the Covid-19 pandemic, the target enrollment was modified and study enrollment was completed after each 15 patients became evaluable in each treatment group (Arm A, Arm B, and Arm C+D combined). We hit this target after a total of 51 patients were enrolled and treated. 53 patients were randomized but two dropped out before receiving an intervention.

Participant milestones

Measure	HCQ Alone (Arm A) Hydroxychloroquine: Hydroxychloroquine	EVE Alone (Arm B) Everolimus: Everolimus	Combination HCQ and EVE (Arm C) Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus	Combination HCQ and EVE 3-mo Delay (Arm D) Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus
Overall Study STARTED	15	15	8	15
Overall Study COMPLETED	15	15	8	13
Overall Study NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer

Baseline characteristics by cohort

Measure	HCQ Alone (Arm A) n=15 Participants Hydroxychloroquine: Hydroxychloroquine	EVE Alone (Arm B) n=15 Participants Everolimus: Everolimus	Combination HCQ and EVE (Arm C+D) n=23 Participants Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus	Total n=53 Participants Total of all reporting groups
Age, Continuous	50.0 years n=5 Participants	45 years n=7 Participants	55 years n=5 Participants	50 years n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Menopausal Status Premenopausal	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Menopausal Status Postmenopausal	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants	36 Participants n=4 Participants
Treatment Adjuvant Chemotherapy	6 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants
Treatment Neoadjuvant Chemotherapy	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Treatment No Chemotherapy	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Receptor Subtype ER+/Her2-	6 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Receptor Subtype ER+/Her2+	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Receptor Subtype TNBC	8 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants
Receptor Subtype ER-/Her2+	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Fifty-one of 53 participants were evaluable for the primary endpoint (excluding the 2 patients randomized to Arm D who withdrew during observation).

For the primary endpoint of feasibility, we employed ongoing Bayesian toxicity monitoring after every 3 participants completed cycle 6, assuming a Beta (1,2) prior, equivalent to one DLT observed in 3 treated participants. Early termination of a treatment arm for toxicity (non-feasibility) would occur if the posterior probability that the toxicity rate exceeds the target maximum of 30% was greater than 75%. Trial enrollment and conduct was significantly impacted by the COVID pandemic, including shortage of HCQ and inability of enrolled patients to travel. To address this, we amended the protocol to allow study Arms C and D to be combined for feasibility assessment, given that the investigational treatment was the same in the two arms, enabling enrollment to be halted when the sample size needed for feasibility assessment was complete for all study treatments. Toxicity was assessed using CTCAE v4.0.

Outcome measures

Measure	HCQ Alone (Arm A) n=15 Participants Hydroxychloroquine: Hydroxychloroquine	EVE Alone (Arm B) n=15 Participants Everolimus: Everolimus	Combination HCQ and EVE (Arm C+D) n=21 Participants Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus
Feasibility: Number of Participants Who Completed 6 Cycles of Protocol Treatment Without Grade 3 or 4 Toxicity Feasible	15 Participants	15 Participants	20 Participants
Feasibility: Number of Participants Who Completed 6 Cycles of Protocol Treatment Without Grade 3 or 4 Toxicity Non-Feasible	0 Participants	0 Participants	1 Participants

Adverse Events

HCQ Alone (Arm A)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

EVE Alone (Arm B)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Combination HCQ and EVE (Arm C+D)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	HCQ Alone (Arm A) n=15 participants at risk Hydroxychloroquine: Hydroxychloroquine	EVE Alone (Arm B) n=15 participants at risk Everolimus: Everolimus	Combination HCQ and EVE (Arm C+D) n=21 participants at risk Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus
Respiratory, thoracic and mediastinal disorders Lung infection	6.7% 1/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Infections and infestations Cellulitis of arm	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	4.8% 1/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Infections and infestations Parainfluenzae virus infection	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	4.8% 1/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.

Other adverse events

Measure	HCQ Alone (Arm A) n=15 participants at risk Hydroxychloroquine: Hydroxychloroquine	EVE Alone (Arm B) n=15 participants at risk Everolimus: Everolimus	Combination HCQ and EVE (Arm C+D) n=21 participants at risk Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus
Gastrointestinal disorders Diarrhea	80.0% 12/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	33.3% 5/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	66.7% 14/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Discomfort	60.0% 9/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	53.3% 8/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	61.9% 13/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Nausea	66.7% 10/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	46.7% 7/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	42.9% 9/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Liver function abnormalities (transaminitis)	46.7% 7/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	20.0% 3/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	71.4% 15/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Mucositis/oral pain	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	73.3% 11/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	66.7% 14/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Anorexia/Weight loss	20.0% 3/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	33.3% 5/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	38.1% 8/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Gastrointestinal disorders Constipation	26.7% 4/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	40.0% 6/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	19.0% 4/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Blood and lymphatic system disorders Neutrophil count decreased	33.3% 5/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	40.0% 6/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	28.6% 6/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Blood and lymphatic system disorders Leukocyte count decreased	26.7% 4/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	40.0% 6/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	33.3% 7/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Blood and lymphatic system disorders Anemia	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	6.7% 1/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	28.6% 6/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Blood and lymphatic system disorders Platelet count decreased	6.7% 1/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	46.7% 7/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	14.3% 3/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Nervous system disorders Visual changes	33.3% 5/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	47.6% 10/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Nervous system disorders Headache	20.0% 3/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	40.0% 6/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	28.6% 6/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Nervous system disorders Dizziness	26.7% 4/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	14.3% 3/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Nervous system disorders Muscle weakness, limb	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	23.8% 5/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Nervous system disorders CPK increased	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	19.0% 4/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	26.7% 4/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	23.8% 5/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Renal and urinary disorders Electrolyte abnormalities	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	46.7% 7/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	52.4% 11/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Endocrine disorders Hyperglycemia	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	20.0% 3/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	14.3% 3/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Cardiac disorders Elevated lipids	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	66.7% 10/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	61.9% 13/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Renal and urinary disorders Elevated creatinine	26.7% 4/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	23.8% 5/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
General disorders Fatigue	40.0% 6/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	46.7% 7/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	52.4% 11/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Skin and subcutaneous tissue disorders SkinRash/Discomfort	20.0% 3/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	53.3% 8/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	57.1% 12/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	13.3% 2/15 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.	19.0% 4/21 • Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment. The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.

Additional Information

Dr Angela DeMichele

University of Pennsylvania

Phone: 2156624000

Email: angela.demichele@pennmedicine.upenn.edu

Results disclosure agreements

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