Trial Outcomes & Findings for Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma (NCT NCT03787303)

Last Updated: 2022-05-13

Results Overview

To prospectively evaluate the progression-free survival in hypothyroid patients with metastatic breast carcinoma who are rendered euthyroid and hypothyroxinemic. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the nadir sum of the longest diameter (SLD) of target lesions, or unequivocal progression (overall level of substantial worsening) in existing non-target lesions, or the appearance of one or more new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

12 months

Results posted on

2022-05-13

Participant Flow

7 participants from one local medical oncology practice were enrolled between March 1, 2019 and March 9, 2022.

All enrolled participants underwent a four day washout period of L-thyroxine (T4) prior to Triiodothyronine (T3) initiation. There were no enrolled participants who were excluded from the study.

Participant milestones

Participant milestones
Measure	Triiodothyronine (T3) Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Triiodothyronine (T3) Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Overall Study Death	1
Overall Study Premature Termination of Study	1

Baseline Characteristics

Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triiodothyronine (T3) n=7 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Age, Continuous	63.7 years STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	7 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	7 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	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	6 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	7 participants n=5 Participants
Duration of time since diagnosis of metastatic disease	62.1 months STANDARD_DEVIATION 79.52 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Last enrolled subject was only able to be followed for 9 months due to early termination of study. Subject not included in primary outcome measure.

Outcome measures

Outcome measures
Measure	Triiodothyronine (T3) n=6 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care	4 Participants

SECONDARY outcome

Timeframe: Study duration, planned was 48 months but actual was 36 months [March 1, 2019 to March 9, 2022] due to premature closure due to planned relocation of the PI.

Population: Outcome was number of practice patients with both metastatic breast cancer and hypothyroidism. Of the 26 identified, 7 patients consented to enroll on the study.

To quantitate the prevalence of hypothyroidism in metastatic breast cancer patients at a community oncology practice.

Outcome measures

Outcome measures
Measure	Triiodothyronine (T3) n=126 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients.	26 Participants

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, and 12 months

Population: Of the 7 subjects enrolled only 5 of the patients completed Quality of Life FACT-B questionnaires for all five timepoint. Two subjects did not complete the 12 months surveys due to death or premature study termination.

Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score comprised of Physical Well Being (PWB), Social Well Being (SWB), Emotional Well Being (EWB), Functional Well Being (FWB), and Breast Cancer Subscale (BCS). Range is 0-148. A higher score indicates higher quality of life. Missing scores were handled by prorating values.

Outcome measures

Outcome measures
Measure	Triiodothyronine (T3) n=7 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire Baseline	114 score on a scale Standard Deviation 24.56
Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire At 3 months	114 score on a scale Standard Deviation 16.80
Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire At 6 months	116 score on a scale Standard Deviation 20.71
Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire At 9 months	112 score on a scale Standard Deviation 26.92
Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire At 12 months	110 score on a scale Standard Deviation 23.68

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, 12 months

Functional Assessment of Cancer Therapy - Breast (FACT-B) Lack of energy on 5 point Likert scale as measured on FACT-B Physical Well-being subscale. Score of 0 indicates no lack of energy with score of 4 indicating total lack of energy.

Outcome measures

Outcome measures
Measure	Triiodothyronine (T3) n=7 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Measurement of Energy Level Across Time Using FACT-B Question. Baseline	2.9 score on a scale Standard Deviation 1.07
Measurement of Energy Level Across Time Using FACT-B Question. 3 months	2.4 score on a scale Standard Deviation 1.3
Measurement of Energy Level Across Time Using FACT-B Question. 6 months	3.0 score on a scale Standard Deviation 1.16
Measurement of Energy Level Across Time Using FACT-B Question. 9 months	3.0 score on a scale Standard Deviation 1.53
Measurement of Energy Level Across Time Using FACT-B Question. 12 months	2.6 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months

To study the average time required to achieve euthyroid hypothyroxinemia state in qualifying patients. Thyroid function laboratory testing was performed at baseline and then at every 4 weekly intervals until 12 weeks then every 3 monthly thereafter, unless thyroid-stimulating hormone (TSH) was abnormal. If a normal TSH level was not achieved by the 12 week visit, repeat TSH measurements were ordered every 4-6 weeks until the TSH value was within the laboratory normal reference range. Initial euthyroid state defined by number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value.

Outcome measures

Outcome measures
Measure	Triiodothyronine (T3) n=7 Participants Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Time to Achieve Euthyroid Hypothyroxinemia State	59.6 days Standard Deviation 50.64

Adverse Events

Triiodothyronine (T3)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Triiodothyronine (T3) n=7 participants at risk Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Infections and infestations Cellulitis	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders ascites	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.

Other adverse events

Other adverse events
Measure	Triiodothyronine (T3) n=7 participants at risk Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
General disorders Edema limbs	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Nail changes	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Nervous system disorders Memory Impairment	42.9% 3/7 • Number of events 3 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Vascular disorders Hypertension	71.4% 5/7 • Number of events 7 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Dyspepsia	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Epistaxis	42.9% 3/7 • Number of events 3 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Infections and infestations Bronchial infection	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Dyspnea	42.9% 3/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Diarrhea	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Fatigue	57.1% 4/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Abdominal pain	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Bloating	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Gastrointestinal disorder: Other hemoccult positive	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Injury, poisoning and procedural complications Bruising	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Musculoskeletal and connective tissue disorders Pain in extremity	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Skin disorder other: Contact dermatitis	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Endocrine disorders Endocrine disorder: Cold intolerance	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Nervous system disorders Dizziness	42.9% 3/7 • Number of events 3 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Weight loss	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Nervous system disorders Headache	28.6% 2/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Chills	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Fever	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Musculoskeletal and connective tissue disorders Arthalgia	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Gastrointestinal disorders: Other - Gastroenteritis	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Non-cardiac chest pain	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Psychiatric disorders Anxiety	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Skin disorder: Other - Chest wall redness	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Nervous system disorders Dysgeusia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Nervous system disorders Anosmia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Malaise	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Cardiac disorders Palpitations	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
General disorders Pain	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Mucositis Oral	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Pruritis	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Skin disorder: Other-onycholysis	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Eye disorders Watering eyes	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Respiratory, thoracic and mediastinal disorders Alopecia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Renal and urinary disorders Urinary incontinence	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Neutrophil count decreased	42.9% 3/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations White blood cell count decreased	42.9% 3/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Blood and lymphatic system disorders Anemia	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Platelet count decreased	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Hypoalbuminemia	28.6% 2/7 • Number of events 4 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Blood bilirubin increased	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Alkaline phosphatase increased	28.6% 2/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Hyperglycemia	57.1% 4/7 • Number of events 7 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Hypoglycemia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Investigations Lymphocyte count decrease	42.9% 3/7 • Number of events 5 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Renal and urinary disorders Blood urea nitrogen increase	14.3% 1/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Renal and urinary disorders Creatinine increase	14.3% 1/7 • Number of events 2 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Hyperkalemia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Metabolism and nutrition disorders Hypercalcemia	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Skin and subcutaneous tissue disorders Nail peeling	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.
Gastrointestinal disorders Tooth loss	14.3% 1/7 • Number of events 1 • Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer.

Additional Information

Shruti Trehan MD

Aultman Hospital

Phone: 3303634162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place