QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer. A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study: Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol. The study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up). Screening Period: The screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled. Treatment Period: Study drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria. Follow-up Period: When participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol. Safety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed. Survival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolny udział w badaniu, podpisanie zgody i zgodę na przestrzeganie wymogów badania.
- •Kobiety w wieku 18-75 lat.
- •Potwierdzony nowotwór piersi o potrójnie ujemnym fenotypie (brak receptorów ER, PR i HER2) na podstawie badania histologicznego.
- •Stadium IV (zaawansowany nowotwór) lub nowotwór nawrotowy/przerzutowy, niezakwalifikowany do operacji, bez wcześniejszego leczenia systemowego zaawansowanego choroby.
- •Kwalifikacja do leczenia preparatem nab-paclitaxel.
- •Co najmniej jeden widoczny guz do zmierzenia podle kryteriów RECIST 1.1.
- •Spodziewana przeżywalność co najmniej 3 miesiące.
- •Ogólny stan zdrowia (ECOG) 0 lub 1 oraz prawidłowe funkcjonowanie wątroby, nerek i krwi.
✗ Disqualifies
- •Alergja na QL1706, anlotinib, nab-paclitaxel lub ich składniki.
- •Niemożność łykania tabletek lub problemy żołądkowo-jelitowe utrudniające wchłanianie leków.
- •Przerzuty do mózgu, opon mózgowych lub rdzenia kręgowego powodujące objawy.
- •Czynna lub potencjalna choroba autoimmunologiczna (z wyjątkami: bielactwo, łysienie, łuszczyca, egzema nierequiring terapii systemowej, niedoczynność tarczycy kontrolowana lekami, cukrzyca typu 1 kontrolowana insuliną).
- •Poważna operacja w ciągu 3 tygodni przed badaniem lub niepełne wyleczenie po zabiegu.
- •Historia przeszczepu narządu lub przeszczepu komórek macierzystych.
- •Zakażenie wirusem HIV.
- •Dodatni wynik na HBV-DNA lub HCV-DNA (liczba kopii >10³).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- May 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Jiangsu Cancer Hospital
Nanjing, China
Trial contact
Lili Zhang
Yuan Yuan
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.