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Background: Recent studies increasingly show the implication of medicinal plants in cancer management. Acmella caulirhiza, a plant belonging to the Asteraceae is traditionally used as an analgesic and anti-inflammatory agent to fight against diseases like cancer. Purpose: This study aimed to evaluate the antitumoral properties of the aqueous extract of leaves and flowers of A. caulirhiza (AE-Ac). Methods: After phytochemical characterization, the cytotoxic activity of AE-Ac on MCF-7 breast cancer lines was carried out using the MTT method. For in vivo study, 36 female Wistar rats (6 weeks old) were randomly divided into 6 groups (n = 6 each) as follows: normal control receiving distilled water (NC), positive control receiving distilled water (DMBA), 3 test groups (receiving either 75, 150 or 300 mg/kg.Bw of AE-Ac (AE-Ac 75, AE-Ac 150 and AE-Ac 300 respectively)) and a reference group (Tam) receiving Tamoxifen at 3.3 mg/kg.Bw. They were fed with a high-fat diet daily. After 2 weeks all groups except the NC group were treated with a single dose of DMBA (7,12-Dimethylbenz (a) anthracene) (50 mg/kg. Bw) by intraperitoneal injection. Daily treatments were administered by intragastric intubation for 12 weeks. At the end, animals were sacrificed after 12 h of fasting and blood was collected for biochemical analysis. The mammary glands were isolated for histological analysis. Results: AE-Ac contains bioactive compounds amongst which stigmasterol, phytol, ellagic acid, phenol, sterols, alkaloids, flavonoids. AE-Ac was more active at 72 h (IC50 = 114.86 µg/mL) on MCF-7 cells. The cancer-treated groups exhibited the lowest percentage of weight gain variation, particularly the group receiving the reference molecule (Tamoxifen) (68.12 %) followed by the AE-Ac 150 group (92.45 %). AE-Ac at 150 and 300 mg/kg-Bw significantly reduced tumor volume and CA 15-3 levels (p = 0.004). Histological analysis of the mammary gland revealed more extensive ascini destruction in the AE-Ac 75 group followed by the DMBA group. Treatment with the 150 mg/kg.Bw ameliorated antioxidant enzyme (SOD and Catalase (p < 0.001)) activities, pro-oxidant levels (NO● and HO●), as well as inflammatory parameters (TNF-α and EGF; RBC, Hb, PLT) (p < 0.05). Conclusion: These results suggest that AE-Ac can be a good candidate as a complementary agent in breast cancer management.