Trial Outcomes & Findings for Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer (NCT NCT03879577)

Last Updated: 2026-01-21

Results Overview

Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

4-6 months

Results posted on

2026-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Neoadjuvant Taxotere and Trastuzumab Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Overall Study STARTED	53
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Neoadjuvant Taxotere and Trastuzumab Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Overall Study Withdrawal by Subject	4
Overall Study Declined surgery	2

Baseline Characteristics

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Age, Continuous	47.6 years n=37 Participants
Sex: Female, Male Female	47 Participants n=37 Participants
Sex: Female, Male Male	0 Participants n=37 Participants
Race/Ethnicity, Customized African/Yoruba	32 Participants n=37 Participants
Race/Ethnicity, Customized African/Ibo	9 Participants n=37 Participants
Race/Ethnicity, Customized African/Other	6 Participants n=37 Participants
Region of Enrollment Nigeria	47 participants n=37 Participants

PRIMARY outcome

Timeframe: 4-6 months

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Number of Participants With Complete Pathologic Response (pCR)	25 Participants

SECONDARY outcome

Timeframe: 4-6 months

Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Number of Participants With Adverse Events	47 Participants

SECONDARY outcome

Timeframe: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years

Time from enrollment to disease recurrence or death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 10 years

Time from pathological complete response to disease recurrence or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy

Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy.	-0.57 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy

Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy.	-0.49 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: From start date of therapy to 6 months post-therapy

Population: Patient completing 6 months of follow-up.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=37 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy.	0.14 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: From start date of therapy to 6 months post-therapy

Population: Patient completing 6 months of follow-up

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=37 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy.	0.22 units on a scale Standard Error 0.29

SECONDARY outcome

Timeframe: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years

The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days

Blood concentrations of Herceptin SC at multiple time points using the peak exposure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days

Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion an average of two years

The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients	1 Participants

SECONDARY outcome

Timeframe: Through study completion an average of two years

The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.

Outcome measures

Outcome measures
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 Participants Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients	0 Participants

Adverse Events

Neoadjuvant Taxotere and Trastuzumab

Serious events: 7 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 participants at risk Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	4.3% 2/47 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.1% 1/47 • 2 years
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.1% 1/47 • 2 years
Investigations Laboratory abnormality	2.1% 1/47 • 2 years
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	2.1% 1/47 • 2 years
Infections and infestations Hepatitis viral	2.1% 1/47 • 2 years
Cardiac disorders Pericardial effusion	2.1% 1/47 • 2 years
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/47 • 2 years
Gastrointestinal disorders Constipation	2.1% 1/47 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.1% 1/47 • 2 years

Other adverse events

Other adverse events
Measure	Neoadjuvant Taxotere and Trastuzumab n=47 participants at risk Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.5% 4/47 • 2 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	36.2% 17/47 • 2 years
Skin and subcutaneous tissue disorders Skin ulceration	6.4% 3/47 • 2 years
Respiratory, thoracic and mediastinal disorders Sore throat	10.6% 5/47 • 2 years
Gastrointestinal disorders Stomach pain	6.4% 3/47 • 2 years
Infections and infestations Upper respiratory infection	8.5% 4/47 • 2 years
Infections and infestations Vaginal infection	6.4% 3/47 • 2 years
Gastrointestinal disorders Vomiting	36.2% 17/47 • 2 years
Eye disorders Watering eyes	12.8% 6/47 • 2 years
Investigations White blood cell decreased	29.8% 14/47 • 2 years
Investigations Investigations - Other, specify	25.5% 12/47 • 2 years
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	8.5% 4/47 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	59.6% 28/47 • 2 years
Nervous system disorders Nervous system disorders - Other, specify	14.9% 7/47 • 2 years
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	10.6% 5/47 • 2 years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	8.5% 4/47 • 2 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	53.2% 25/47 • 2 years
General disorders Pain	21.3% 10/47 • 2 years
Musculoskeletal and connective tissue disorders Pain in extremity	10.6% 5/47 • 2 years
Cardiac disorders Palpitations	6.4% 3/47 • 2 years
Nervous system disorders Paresthesia	6.4% 3/47 • 2 years
Nervous system disorders Peripheral motor neuropathy	10.6% 5/47 • 2 years
Nervous system disorders Peripheral sensory neuropathy	25.5% 12/47 • 2 years
Investigations Platelet count decreased	12.8% 6/47 • 2 years
Skin and subcutaneous tissue disorders Pruritus	12.8% 6/47 • 2 years
Skin and subcutaneous tissue disorders Rash acneiform	12.8% 6/47 • 2 years
Gastrointestinal disorders Abdominal pain	6.4% 3/47 • 2 years
Investigations Alanine aminotransferase increased	6.4% 3/47 • 2 years
Skin and subcutaneous tissue disorders Alopecia	72.3% 34/47 • 2 years
Blood and lymphatic system disorders Anemia	29.8% 14/47 • 2 years
Metabolism and nutrition disorders Anorexia	8.5% 4/47 • 2 years
Musculoskeletal and connective tissue disorders Back pain	23.4% 11/47 • 2 years
Investigations Blood bilirubin increased	8.5% 4/47 • 2 years
Musculoskeletal and connective tissue disorders Bone pain	8.5% 4/47 • 2 years
Reproductive system and breast disorders Breast pain	23.4% 11/47 • 2 years
Cardiac disorders Chest pain - cardiac	6.4% 3/47 • 2 years
General disorders Chills	8.5% 4/47 • 2 years
Gastrointestinal disorders Constipation	8.5% 4/47 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	21.3% 10/47 • 2 years
Gastrointestinal disorders Diarrhea	74.5% 35/47 • 2 years
Nervous system disorders Dizziness	12.8% 6/47 • 2 years
Gastrointestinal disorders Dry mouth	12.8% 6/47 • 2 years
Gastrointestinal disorders Dysphagia	12.8% 6/47 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	6.4% 3/47 • 2 years
General disorders Edema limbs	6.4% 3/47 • 2 years
Investigations Ejection fraction decreased	6.4% 3/47 • 2 years
General disorders Fatigue	12.8% 6/47 • 2 years
Blood and lymphatic system disorders Febrile neutropenia	6.4% 3/47 • 2 years
General disorders Fever	10.6% 5/47 • 2 years
Musculoskeletal and connective tissue disorders Generalized muscle weakness	36.2% 17/47 • 2 years
Nervous system disorders Headache	36.2% 17/47 • 2 years
Vascular disorders Hot flashes	10.6% 5/47 • 2 years
Vascular disorders Hypertension	6.4% 3/47 • 2 years
Metabolism and nutrition disorders Hypokalemia	17.0% 8/47 • 2 years
General disorders Infusion site extravasation	6.4% 3/47 • 2 years
General disorders Injection site reaction	8.5% 4/47 • 2 years
Psychiatric disorders Insomnia	25.5% 12/47 • 2 years
General disorders Malaise	17.0% 8/47 • 2 years
Gastrointestinal disorders Mucositis oral	6.4% 3/47 • 2 years
Skin and subcutaneous tissue disorders Nail discoloration	21.3% 10/47 • 2 years
Gastrointestinal disorders Nausea	31.9% 15/47 • 2 years
Investigations Neutrophil count decreased	27.7% 13/47 • 2 years
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	17.0% 8/47 • 2 years
Cardiac disorders Cardiac disorders - Other, specify	8.5% 4/47 • 2 years
Eye disorders Eye disorders - Other, specify	19.1% 9/47 • 2 years
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	38.3% 18/47 • 2 years
General disorders General disorders and administration site conditions - Other, specify	34.0% 16/47 • 2 years
Infections and infestations Infections and infestations - Other, specify	21.3% 10/47 • 2 years

Additional Information

Theodore Karrison (Research Professor)

University of Chicago

Phone: (773) 702-2453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place