18 and older, female only, 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.
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall ResponsePrimary· Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all m
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
62.5
45.7 – 79.3
Percentage of Participants With a Total ResponseSecondary· Evaluated every 2 cycles, up to a maximum of 39 cycles.
Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
81.3
67.7 – 94.8
Time to Disease ProgressionSecondary· Assessed every 2 cycles, up to a maximum of 39 cycles.
Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression wa
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
16.6
7.5 – 26.5
Duration of ResponseSecondary· Assessed every 2 cycles, up to a maximum of 39 cycles.
Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% incr
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
17.8
15.9 – 37.0
Overall Patient SurvivalSecondary· From Day 1 until approximately 44 months.
Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
NA
NA – NA
Number of Participants With Adverse Events (AEs)Secondary· Day 1 up to 39 cycles
A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward me
Number with any treatment emergent AE
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
32
Number with any treatment-related AE
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
31
Number with any Grade 3/4 TEAE
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
20
Number with any serious AE
Group
Value
95% CI
Albumin-bound Paclitaxel, Carboplatin + Herceptin
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 up to 39 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06771622 — Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· active not recruiting
NCT06404736 — QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer
· Phase 2
· not yet recruiting
NCT06404463 — QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer
· Phase 2
· not yet recruiting
NCT05653817 — Advanced or Metastatic Cholangiocarcinoma
· NA
· unknown
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 25 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00093145.