Esophageal Neoplasms, Stomach Neoplasms
Conditions
Brief summary
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Interventions
DRUGIrinotecan
DRUGTrastuzumab
DRUGOxaliplatin
DRUGLeucovorin
DRUGFluorouracil
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction. 2. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam. 3. Prior single modality radiation therapy is allowed. 4. At least 18 years of age. 5. ECOG performance status ≤ 2 6. Normal bone marrow and organ function as defined below: 1. Absolute neutrophil count ≥ 1,500/mcl 2. Platelets ≥ 100,000/mcl 3. AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN 4. Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal 5. LVEF ≥ 50% 7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. 8. Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed). 9. Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward.
Exclusion criteria
1. Chemotherapy in the 6 months prior to registration. 2. Any active malignancy within 3 years that may alter the course of esophageal cancer (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed) 3. Receiving any other investigational agents at the time of registration. 4. Known untreated brain metastases. These patients must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study. 6. Previous therapy for metastatic gastroesophageal cancer. Previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months.. 7. A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia. 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 9. Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 14 days of study entry. 10. Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with trastuzumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Objective Response | Through completion of treatment (estimated to be 4 months) | * Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months) | Duration of time from start of treatment to time of progression. Progression is defined as At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Overall Survival (OS) | Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months) | Overall survival is defined as the time interval from date of diagnosis to date of death from any cause. |
| Progression Free Survival | Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months) | Duration of time from start of treatment to time of progression or death, whichever occurs first. |
| Duration of Response | Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months) | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented |
| Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | 30 days after completion of treatment (estimated to be 5 months) | — |
| Clinical Benefit Rate | Through completion of treatment (estimated to be 4 months) | * Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 11/08/2013 and closed to participant enrollment on 07/23/2018.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: FOLFIRINOX (HER2-negative) Irinotecan 180 mg/m2 IV on Days 1 & 15.
Oxaliplatin 85 mg/m2 IV on Days 1 & 15.
Leucovorin 400 mg/m2 IV on Days 1 & 15.
Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. | 41 |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.
Irinotecan 180 mg/m2 IV on Days 1 & 15.
Oxaliplatin 85 mg/m2 IV on Days 1 & 15.
Leucovorin 400 mg/m2 IV on Days 1 & 15.
Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. | 26 |
| Total | 67 |
Baseline characteristics
| Characteristic | Arm A: FOLFIRINOX (HER2-negative) | Total | Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
|---|---|---|---|
| Age, Continuous | 59 years | 59 years | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 67 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 63 Participants | 25 Participants |
| Region of Enrollment United States | 41 participants | 67 participants | 26 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 56 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 41 | 20 / 26 |
| other Total, other adverse events | 41 / 41 | 26 / 26 |
| serious Total, serious adverse events | 18 / 41 | 8 / 26 |
Outcome results
Primary
Number of Participants With an Objective Response
* Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Through completion of treatment (estimated to be 4 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Number of Participants With an Objective Response | 25 Participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Number of Participants With an Objective Response | 22 Participants |
Secondary
Clinical Benefit Rate
* Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Through completion of treatment (estimated to be 4 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Clinical Benefit Rate | 33 Participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Clinical Benefit Rate | 22 Participants |
Secondary
Duration of Response
Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Duration of Response | 5.8 months |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Duration of Response | 10.5 months |
Secondary
Overall Survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Overall Survival (OS) | 15.5 months |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Overall Survival (OS) | 19.6 months |
Secondary
Progression Free Survival
Duration of time from start of treatment to time of progression or death, whichever occurs first.
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Progression Free Survival | 8.4 months |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Progression Free Survival | 13.8 months |
Secondary
Time to Progression (TTP)
Duration of time from start of treatment to time of progression. Progression is defined as At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Time to Progression (TTP) | 8.0 months |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Time to Progression (TTP) | 13.9 months |
Secondary
Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events
Time frame: 30 days after completion of treatment (estimated to be 5 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Platelet count decreased | 3 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Fatigue | 4 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anorexia | 3 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hematemesis | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Dehydration | 4 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Laparoscopy surgery | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hypokalemia | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anal Fistula | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Back pain | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pain | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 2 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Nausea | 2 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Syncope | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Sepsis | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Dyspnea | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Febrile neutropenia | 2 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pleural embolism | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Lung infection | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Skin infection | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Peripheral ischemia | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Thromboembolic event | 4 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pneumonia | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Diarrhea | 4 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Enterocolitis | 0 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hypernatremia | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hemorrhoids | 0 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Vomiting | 3 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | G-tube infection | 0 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Neutrophil count decreased | 19 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Neutropenic entercolitis | 0 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anemia | 1 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Alkaline phosphatase increased | 0 participants |
| Arm A: FOLFIRINOX (HER2-negative) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Abdominal pain | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Alkaline phosphatase increased | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anemia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Febrile neutropenia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anal Fistula | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Diarrhea | 5 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hematemesis | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Nausea | 2 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Peripheral ischemia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Vomiting | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Fatigue | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Laparoscopy surgery | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pain | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Sepsis | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Lung infection | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pneumonia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hypernatremia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Neutrophil count decreased | 8 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Platelet count decreased | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Anorexia | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Dehydration | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hypokalemia | 2 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Back pain | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Syncope | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Dyspnea | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Pleural embolism | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Skin infection | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Thromboembolic event | 0 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Abdominal pain | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Enterocolitis | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Hemorrhoids | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | G-tube infection | 1 participants |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events | Neutropenic entercolitis | 1 participants |