NCT03414684

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Active, enrolled Phase 2 Results posted Last updated 29 September 2025

What this trial tests

Phase 2 trial testing Carboplatin in Breast Cancer in 78 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 January 2018

Primary endpoint
28 September 2021

30 July 2026

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	30 January 2018
Primary completion	28 September 2021
Estimated completion	30 July 2026
Sites	10 locations across United States

Drugs / interventions tested

• Carboplatin (Carboplatin) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival Primary · Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	4.2	2.7 – 11.5
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	5.5	4.4 – 19.2

Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	25.0	11.5 – 43.4
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	23.3	9.9 – 42.3

Objective Response Rate by Immune-Related Response Criteria (irRC) Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	28.1	13.7 – 46.7

Overall Survival Secondary · Assessed from date of randomization until the date of death from any cause, up to 3.5 years

Defined as the time from randomization to death due to any cause, or censored at date last known alive

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	16.8	10.4 – NA
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	11.1	8.2 – 24.4

Clinical Benefit Rate Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	34.4	18.6 – 53.2
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	33.3	17.3 – 52.8

Duration of Response Secondary · Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	19.3	16.8 – NA
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	7.7	2.7 – NA

Time to Objective Response Secondary · Assessed from randomization to the time of first response, up to 3.5 years

Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	4.6	4.0 – NA
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	11.2	4.7 – NA

Progression-free Survival Among PD-L1-positive Patients Secondary · Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	8.3	2.5 – NA
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	4.7	1.6 – NA

Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	23.1	5.0 – 53.8
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	27.3	6.0 – 61.0

Objective Response Rate by irRC Among PD-L1-positive Patients Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	30.8	9.1 – 61.4

Overall Survival Among PD-L1-positive Patients Secondary · Assessed from date of randomization until the date of death from any cause, up to 3.5 years

OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	17.6	4.9 – NA
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	10.7	6.7 – NA

Clinical Benefit Rate Among PD-L1-positive Patients Secondary · Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Group	Value	95% CI
Arm A: Carboplatin + Nivolumab	30.8	9.1 – 61.4
Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	36.4	10.9 – 69.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Carboplatin + Nivolumab

Serious: 10/37 (27%)

Deaths: 24/37

Arm B: Carboplatin

Serious: 11/38 (29%)

Deaths: 17/38

Arm B: Carboplatin -- Crossover

Serious: 6/18 (33%)

Deaths: 10/18

Serious adverse events (38 terms)

Reaction	System	Arm A: Carboplatin + Nivol…	Arm B: Carboplatin	Arm B: Carboplatin -- Cros…
Platelet count decreased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—
Pain	General disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Fever	General disorders	—	—	—
Infusion related reaction	General disorders	—	—	—
Allergic reaction	Immune system disorders	—	—	—
Infections and infestations - Other, specify	Infections and infestations	—	—	—
Joint infection	Infections and infestations	—	—	—
Lung infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Blood bilirubin increased	Investigations	—	—	—
White blood cell decreased	Investigations	—	—	—
Cognitive disturbance	Nervous system disorders	—	—	—
Confusion	Psychiatric disorders	—	—	—
Breast pain	Reproductive system and breast disorders	—	—	—
Hypotension	Vascular disorders	—	—	—

Other adverse events (102 terms — click to expand)

Reaction	System	Arm A: Carboplatin + Nivol…	Arm B: Carboplatin	Arm B: Carboplatin -- Cros…
Platelet count decreased	Investigations	—	—	—
Fatigue	General disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Pain	General disorders	—	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
White blood cell decreased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Infusion related reaction	General disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—
Edema limbs	General disorders	—	—	—
Fever	General disorders	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Breast pain	Reproductive system and breast disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Platelet count decreased, Anemia, Colitis, Neutrophil count decreased, Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, Dyspnea, Hypoxia, Pain.

Data from ClinicalTrials.gov NCT03414684 adverse events section.

Sponsor's own description

This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body.

The interventions involved in this study are:

* Carboplatin
* Nivolumab

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insights into Molecular Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment.
   Garrido-Castro AC, Lin NU, Polyak K. · · 2019 · cited 1061× · PMID 30679171 · DOI 10.1158/2159-8290.cd-18-1177
2. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
3. The Evasion Mechanisms of Cancer Immunity and Drug Intervention in the Tumor Microenvironment.
   Kim SK, Cho SW. · · 2022 · cited 300× · PMID 35685630 · DOI 10.3389/fphar.2022.868695
4. Triple-Negative Breast Cancer: Current Understanding and Future Therapeutic Breakthrough Targeting Cancer Stemness.
   Lee KL, Kuo YC, Ho YS, Huang YH. · · 2019 · cited 164× · PMID 31505803 · DOI 10.3390/cancers11091334
5. The clinical promise of immunotherapy in triple-negative breast cancer.
   Vikas P, Borcherding N, Zhang W. · · 2018 · cited 111× · PMID 30573992 · DOI 10.2147/cmar.s185176
6. Combination of Ipilimumab and Nivolumab in Cancers: From Clinical Practice to Ongoing Clinical Trials.
   Kooshkaki O, Derakhshani A, Hosseinkhani N, Torabi M, et al · · 2020 · cited 95× · PMID 32580338 · DOI 10.3390/ijms21124427
7. BRCA1 and Breast Cancer: Molecular Mechanisms and Therapeutic Strategies.
   Fu X, Tan W, Song Q, Pei H, et al · · 2022 · cited 77× · PMID 35300412 · DOI 10.3389/fcell.2022.813457
8. Triple-negative breast cancer: A run-through of features, classification and current therapies.
   Manjunath M, Choudhary B. · · 2021 · cited 76× · PMID 33986872 · DOI 10.3892/ol.2021.12773